Snapshot of Stem Cell Companies in Australia
2016
Second Edition
Snapshot of Stem Cell Companies in Australia
About the NSW Stem Cell Network
The NSW Stem Cell Network is a professional community with
an interest in all forms of stem cells.
The Network strategy is to work with the scientific, health and
medical research communities, the higher education sector and
business to promote growth and innovation to achieve positive
outcomes for the people of NSW. Our work encompasses
science, medicine, ethics, law, business and public awareness of
stem cells.
Objectives of the NSW Stem Cell Network
The Network, since its establishment in 2002, has worked towards:


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Facilitating communication among members to promote the use of stem cells within an ethical
framework;
Acting as a source of information on stem cells for the community and as a public advocate for them;
Promoting the development of resources to support the use of stem cells within New South Wales;
Enhancing the R&D and/or commercialisation potential of stem cells within New South Wales.
Contact us:
www.stemcellnetwork.org.au
E: [email protected]
P: +61 (02) 9552 9981
About this Snapshot
A list of companies was formulated, largely compiled from information that was publicly available. A
questionnaire was sent out to relevant company representatives, and the information was compiled into this
Snapshot. Hence, the information contained within this Snapshot is up to date and relevant as of July 2016.
A draft was circulated back to the company representatives for approval before its publication and launch at
International Biofest 2016 (24-27th October, Melbourne).
The second edition of the Snapshot includes a more comprehensive list of companies and contains details of
clinical trials run by cell therapy companies (page 28).
Disclaimer:
The information contained in the Snapshot of Stem Cell Companies in Australia: November 2015 is intended solely for
general information. This publication must not be relied upon as a substitute for medical, investment or other
professional advice. You are encouraged to speak with the relevant contacts provided in the Snapshot for further
information. This Snapshot should not be read as reflecting the policies of the NSW Stem Cell Network, its Executive,
officers or members. Nor does the Snapshot represent an endorsement of the processes, procedures and technologies
described therein. The NSW Stem Cell Network does not accept any liability arising in any way from information
contained in this publication, including by reason of negligence for errors or omissions in the information. Only
companies that have agreed to be published in the Snapshot were included and, any liability resides with them.
Snapshot of Stem Cell Companies in Australia
2
Forward ……………………………………………………………………………………………………………………..……….……………
4
Commercialisation Opportunities …………………………………………………………………………………..……….….……
6
Companies
Australian-based Stem Cell Companies……………………………………………………………………….…..……………
8
Mesenchymal Lineage Adult Stem Cells
Mesoblast Ltd………………………..…………………………………………………………..…………………………..………..………
9
Mesenchymal Stem Cells
Cynata Therapeutics Ltd………………………………………………………………………………………..……………….…........
10
Regeneus Ltd……………………………………………………………………………………………………………….………….………..
11
Biobanking
CellCare…………………………………………………………………………………………………………………………………………….
12
Biotechnology
Calimmune Australia Pty Ltd………..…………………………………………………………………………………………...........
13
Genea Biocells Pty Ltd..………………………………..…………………………………………………………………………………..
Manufacturing and Medical Devices
Orthocell……………………………………………………………………………………………………………………………...……….....
14
15
Manufacturing
Cell Therapies Pty Ltd..………………………………..…………………………………………………………………………..……….
16
Medical Devices
Avita Medical Ltd……..………………………………..………………………………………….………………………..……..…........
17
Overseas Stem Cell Companies with Branches in Australia ………………………………………...……….…......
18
Cytomatrix……………………………………………………………………………………………………………………...………………..
19
TerumoBCT Australia Pty Ltd…………………..………………………………..……….………………...………………..………..
20
Laboratory Supply Companies
BD Biosciences…………………………………………………………………………………..……………………………………………..
21
Bioscientific……………………………………………………………………………………………………………………………………….
21
Coherent Scientific …………………………………………………………………………………………………………………………..
22
Eppendorf……………………………………………………………………………………………..………………...…………………......
22
In Vitro Technologies Pty Ltd…………..………………………………………………………………………………………..……...
23
Lonza……………………………………………..…………………………………………………………………………………………………
23
Merck Millipore………………………………………………………………………………………………………………………………..
24
Miltenyi Biotec and MACS Technology …………………………………………………………………………………………….
24
PreproTech………………………………………………………………………………………………………………………………………
25
Sapphire Bioscience.…………………………………………………………………………………………………………………………
25
Scientifix……………………………………………………………..………………………………………………………………………......
26
STEMCELL Technologies Inc….………………………………………………..………………………………………………………..
26
ThermoFisher …………………………………………………………………………………………………………………………….......
27
VWR International……………………………………………………………………………………………………………………………
27
List of clinical trials run by cell therapy companies……………………………………………………………………………
28
Snapshot of Stem Cell Companies in Australia
3
Forward
Great progress has been made since the first attempts to treat diseases using stem cells over the past 50 years, with blood
disorders being the lead disease treated. In Australia, there are more than 150 people with acute leukaemia treated
annually with haemopoietic stem cells. In this Century, the use of stem cells for other disorders is being contemplated
and trialled. These include multiple sclerosis, diabetes, macular degeneration, spinal cord lesions and cancer. Despite
the innovative advances in this field, the full potential of cell therapies is yet to be realized.
The NSW Stem Cell Network has nurtured the stem cell community for the past 14 years to grow and advance stem cell
research and development. The Network has over 500 members around Australia including clinicians, researchers, policy
developers, members of Government, lawyers, ethicists, students, patients and companies, who are all passionate
advocates working together for the growth of the stem cell industry. With this report, our intention is to elevate stem cell
business in Australia to the next level.
In the snapshot, we profile current stem cell companies, some of whom are licensed by the TGA, and are carrying out
ethically approved controlled stem cell clinical trials registered with an appropriate entity. Details of Australian clinical
trials run by stem cell therapy companies can be found in page 28 of this document.
The growing number of stem cell trials registered in Australia and worldwide reflect recent efforts to expand the use of
cell therapies to a broader range of conditions. However, maximum research and development potential can only be
achieved with the provision of substantial support from government bodies and the private sector.
Stem cell research and development is particularly flourishing in countries where there is plenty of investment from both
Government and the private sector. In the US, Singapore, Israel and Canada, there is a solid business model for
progressing innovative stem cell research. Meanwhile, changes in regenerative medicine regulations in Japan have
attracted great international interest for the Japanese market, especially due to accelerated commercialisation
opportunities.
In Australia, the commercialisation of Stem Cells has been an enormous challenge over the past ten years for a number of
reasons. The perception of being a risky investment in biotechnology stem cell companies, lack of strong Government
funding in stem cells and the small pool of specialist stem cell businessman that sit on company boards and mentor the
growth in stem cell companies, are just a few of the hurdles.
A number of companies have chosen to seek investment from overseas organisations to assist their growth in Australia,
whilst others have secured a foot of their business overseas to create a channel for investment. Some companies are
desperately seeking partnerships with pharmaceutical companies, with minimal success.
The companies progressing with autologous stem cell products already on the market for patients with sports or other
injuries have come up against other challenges relating to a relatively unregulated marketplace including scrutiny from
Government regulatory bodies.
According to a number of industry experts, there is a need for stem cell organisations including companies to come
together under one banner with a united voice. Importantly, the stem cell group needs to have influential advocates who
can lead the charge in stem cells.
When the Hon Jillian Skinner, NSW Minister for Health, opened the 23rd of the NSW Stem Cell Network, she advised her
strong support for the translation of stem cell research from the lab to the clinic. Well known businessman, Frank Lowy
invested over $5 million into stem cell research. More advocates like this are needed in Australia to drive the business of
stem cells.
The Regulations
In pursuing the goal of developing stem cell therapies, there is the need to obtain regulatory approval for both
development of the product, and for conducting clinical trials to test safety and efficacy.
The Therapeutics Goods Administration (TGA) provides guidance and advice concerning all of the above, with the
regulatory framework being that for biologicals. It is advantageous for discussions to be held with relevant officers of the
TGA prior to proceeding with clinical trials, to help circumvent problems that might otherwise arise.
Snapshot of Stem Cell Companies in Australia
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The conducting of clinical trials with stem cells requires approval from a duly constituted Human Research Ethics
Committee. This will require reasonable pre-clinical evidence that they might work in humans, and that the cells are well
characterized, and free of microbiological contamination. Good Clinical Practice is needed.
In addition, before the Trial can proceed, acknowledgement by the TGA that the Trial is being conducted (Clinical Trial
Notification), or a more thorough assessment of it by the TGA (Clinical Trial Exemption), is needed. If the use of the stem
cells has been approved by the Regulatory Body of another country, especially the Food and Drug Administration of the
USA, it is probable that the TGA will support its use in a trial in Australia.
Registration of stem cells as a treatment for a medical condition requires them to have been tested in several phases,
initially for safety (phase 1), then efficacy in a relatively small study (phase 2), and finally at multiple sites in a larger
cohort of people (phase 3). Evidence that the therapy will work usually requires it to be tested against a control group,
to determine the placebo effect, which can be quite large. Registration of the product occurs after phase 3 trials.
Sometimes, stem cells will be placed in a device before being used. This might be a scaffold to allow the stem cells to
attach and proliferate more readily, or an immunoisolation system to protect them from the recipients’ immune system.
Approval for the use of such devises also comes under the biologics framework.
Unregulated by the TGA as detailed in the Excluded Goods Order is the possibility for a clinician to obtain cells from his/
her patient, process them, and re-administer them to that person, e.g., for the treatment of sports injuries. Some
members of the autologous stem cell industry have written a Code of Conduct to encourage its self-regulation, and the
TGA is currently examining what form of regulation would best serve Australia in this contentious area.
The NSW Stem Cell Network has committed to compiling this list of stem cell companies as the next step forward to
drive the development of the stem cell industry in Australia, hopefully providing insight around where Australia is at
right now. Combining this information with the Snapshot of Stem Cell Research in Australia published in 2014 by the
National Stem Cell Foundation of Australia we believe will create a solid landscape of stem cells R & D in our country .
Professor Bernie Tuch
Dr Daniella Goldberg
NSW Stem Cell Network
NSW Stem Cell Network
Director
Executive
Dr Goldberg is a Director of the public relations firm Gene Genie Media; Professor Tuch is an endocrinologist and nonexecutive Director of the biotechnology company Living Cell Technologies Ltd.
Snapshot of Stem Cell Companies in Australia
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Commercialisation Opportunities
While stem cells hold incredible potential and opportunities, it is a field that also presents many challenges.
Being a bespoke technology customised for each patient, the clinical development program is expensive and
economies of scale are smaller. Attracting investors has sometimes been difficult due to the risks
outweighing the benefits, and the high cost of producing the product. Cost issues are compounded by the
reliance on materials from other industries.
Speaking at AusBiotech’s Regenerative Medicine Symposium 2015, Carryn King, Novartis’s New Products
Manager Oncology/ Haematology, said that big pharma haven’t been in the cellular therapies space for long
and that new approaches are required. The path and timeline for funding are challenging, and highly
dependant on the offering. There is complexity across all functions – manufacturing, consumer market access
(such as how should patients be prioritised and scheduled) and commercialisation model considerations.
There are also greater education needs for investors and patients, and companies are learning what
questions to ask.
Speaking at the same Symposium, Paul Anderson, Managing Director of Orthocell said the challenges are
ongoing on a daily basis: “There are no risk-free avenues available, work out what you can and can’t control”.
He said companies need to ask the following questions:
Is there a genuine market need?
How internationally transferable is it?
Will it cost more to make than sell?
Can we protect IP?
Do we have the money? Can we raise it?
“Investors need to understand your business. There’s a lot of peripheral noise in the stem cell space, we need
to show who’s doing it properly.”
One recent success story is Australian biotech Mesoblast, the shares of which rose by 22% in April 2015 after
US-based biotech giant Celgene Corporation invested $58.5 million to buy about 4.7% of Mesoblast and get
access to its anti-cancer drugs. Celgene will also get a six-month right of first refusal on Mesoblast’s
proprietary adult stem cell product candidates for the prevention and treatment of acute graft versus host
disease, certain cancers, inflammatory bowel diseases and organ transplant rejection (this was later extended
for another six months).
In a Market Insight report for the September 2015 edition of Australasian BioTechnology, Rhenu Bhuller of
Frost and Sullivan wrote: “The Asia-Pacific stem cell market was valued at US$7.10 billion in 2014 and is
projected to increase to US$18.71 billion by 2018 growing at a compound annual growth rate of 27.3% for
the period. This growth is a result of the increasing regulatory support regarding stem cell research,
advancements in regenerative medicine and the opportunities arising from stem cell therapies. These
opportunities include contract research outsourcing and an increase in the patient population with
neurological and other chronic conditions in the region. Japan, Singapore and South Korea are the
frontrunners and set to dominate the Asia Pacific stem cell market in the coming years.
“Australia has started to develop critical infrastructure needed for regenerative medicine research and there
have been some achievements such as the success of companies like Mesoblast as well as the $153 million
Australian Regenerative Medicine Institute (ARMI) at the Monash University Clayton campus. Australia is also
starting to gain ground internally with partnerships like the ARMI-MDI Biological Laboratory one which will
enable knowledge sharing and hopefully accelerate discoveries in areas such as heart disease, autoimmune
diseases and musculoskeletal disorders.”
Snapshot of Stem Cell Companies in Australia
6
“However, there are still only a handful of companies with products in commercialisation. One of the barriers
is the cost and on a more practical level, the supply chain that will enable larger access to such therapies.
Whilst the Asia Pacific region holds high potential for the commercialisation of regenerative medicine, having
to transfer material from Australia to Asia and vice versa is a costly exercise. However, opportunities are
present and results would best be attained through partnerships between Australian researchers and
companies with those in Asia, for example Japan or Korea, which could be a combination of consultative
services and lab or on-site production facilities,” wrote Ms Bhuller.
The CRC for Cell Therapy Manufacturing, based at University of South Australia, is a project-based global
network established to help facilitate the cost-effective manufacture and rapid translation of cell therapies
into clinical practice.
Dr Tim Oldham, Chief Executive Officer, Cell Therapies Pty Ltd, writing in the September 2015 edition of
Australasian Biotechnology, stated: “A whole new manufacturing and supply industry must be created if
thousands of patients are to benefit from these breakthrough therapies. Traditional pharmaceuticals are
inert, largely temperature stable and can be manufactured centrally in batches of thousands or millions of
doses to sit on a pharmacy shelf until needed. Cellular therapies are patient specific, living products that are
inherently fragile, have very short shelf-lives unless stored in liquid nitrogen and are highly variable. A clinical
prescription initiates and just-in-time, time critical production process with each batch producing a single
product for one patient. Today these processes are very manual and very expensive.”
“An advanced manufacturing eco-system is developing around these new therapies. Cell Therapies already
collaborates with Invetech Ltd in Melbourne for process automation, the CRC for Cell Therapy Manufacturing
in Adelaide for cost reducing processes and Peter Mac for optimising cell collection by apheresis. Australia
has a genuine opportunity to be more than a local manufacturing hub – it can also become an advanced
manufacturing leader in this field.”
Australia faces the challenge of needing a regulatory approach that enables Australian companies to be part
of this exciting medical frontier, but also addresses the safety and quality concerns. Structural weaknesses in
regulation in some other countries have seen some patients travel overseas to access “stem cell therapies”
the safety and efficacy have yet to be established . To realise the clinical promise of stem cells, companies
must address the challenges of how to reduce risk, how to increase cost-effectiveness and eventually how to
deal with explosive demand.
R & D Tax Incentive and other tax reform
The 2011 introduction of the R&D Tax Incentive was a momentous point for Australian innovation. The
Incentive is actively attracting companies from around the world to bring their R&D to Australia and
supporting medical R&D via small innovation companies. Start-up innovation companies, especially
biotechnology companies trading in loss, are the biggest beneficiaries from the Tax Incentive’s 43.5%
refundable component. The legislation also benefits large innovative companies by reducing the cost of
conducting eligible R&D activities in Australia, making Australia a more competitive location for conducting
biomedical and pharmaceutical R&D and clinical trials.
Glenn Cross, CEO, AusBiotech
AusBiotech Investment offers a series of state-based, national and international investor events as a platform
to showcase Australian biotech companies to potential partners and investors. The annual Australia Biotech
Invest and Asia Biotech Invest are the keystone events. More details can be found at www.ausbiotech.org/
investment
Snapshot of Stem Cell Companies in Australia
7
Australian-based
Stem Cell Companies
Snapshot of Stem Cell Companies in Australia
8
Mesenchymal Lineage Adult Stem Cells (MLCs) comprising Mesenchymal Precursor
Cells (MPCs) and culture-expanded Mesenchymal Stem Cells (MSCs)
Mesoblast Limited is a global leader in cellular medicines. The Company has leveraged its proprietary
technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to
establish a broad portfolio of late-stage product candidates.
Mesoblast Limited is committed to delivering innovative cellular medicines. Its allogeneic, ‘off-the-shelf’ cell
product candidates target significantly advanced stages of diseases where there are high unmet medical needs.
Mesoblast’s portfolio of mesenchymal lineage adult stem cell-derived product candidates each has its own
distinct technical characteristics, target indications, individual reimbursement strategy, separate
commercialization potential, and unique partnering opportunities.
PIPELINE
Mesoblast has established what it believes is the industry’s most clinically advanced and diverse portfolio of
cellular medicines. There are five programs, two of which are partnered, in active Phase 3 clinical studies or
Phase 3-ready, and four programs in Phase 2. All of the Company’s clinical programs target significant,
under-served therapeutic areas including cardiac diseases, immune-mediated and inflammatory conditions,
oncology and hematology diseases, and spine orthopedic disorders.
LATEST NEWS
Mesoblast licensee in Japan has received Japanese Government regulatory approval for its mesenchymal stem
cell-based product, which is the first allogeneic regenerative medicine product to receive full approval in Japan.
Mesoblast believes it is well positioned to have the first industrially manufactured allogeneic stem cell product
approved in the United States.
CEO: Professor Silviu Itescu
Established in Australia in 2004
ABN: 68 109 431 870
Status: Public
www.mesoblast.com
CONTACT
Julie Meldrum | Global Head of Corporate Communications
P: +61 (0)3 9639 6036
E: [email protected]
Snapshot of Stem Cell Companies in Australia
9
Mesenchymal Stem Cells
Cynata Therapeutics Ltd is developing a proprietary therapeutic stem cell platform technology, Cymerus™, which
arose from the University of Wisconsin-Madison, a world leader in stem cell research. Cymerus™ addresses a
critical shortcoming in existing methods of production of mesenchymal stem cells (MSCs) for therapeutic use: the
ability to achieve economic manufacture at commercial scale
Limitations in conventional methods of MSC production include the dependence upon donors, the variability between
donors, the relative scarcity of MSCs in adult tissue, and the low proliferative capacity of adult stem cells compared to
pluripotent stem cells. Cynata believes that the Cymerus™ technology may address all of these issues, and the
Company's activities in relation to the Cymerus™ technology are aimed at achieving that. This uniquely places Cynata
to capitalise on the flourishing field of stem cell therapeutics. The Company has been covered in highly favourable
equity research analyses published by Baillieu Holst, BBY, SeeThru Equity, Rodman & Renshaw and Shaw & Partners.
PIPELINE
There has been extensive interest in the development of MSCs as therapeutic agents, in light of their ability to secrete
bioactive molecules such as cytokines, chemokines, and growth factors, in addition to their immunosuppressive and
immunoregulatory properties. There are currently over 300 active clinical trials of MSCs, covering an extremely wide
range of therapeutic indications, including haematological, cardiovascular, orthopaedic, gastrointestinal and
autoimmune disorders, among others. Cynata is currently planning a Phase 1 clinical study in graft-versus-host
disease (GvHD) for the Company’s lead MSC product, CYP-001. Approval for the trial has been granted by the UK
Medicines and Healthcare products Regulatory Agency (MHRA) and it is expected to commence late in 2016. It is
envisaged that this study will serve a clinical proof of concept, and a basis for further development in numerous other
indications, such as those in which MSCs from other sources have previously been investigated. Cynata is also
investigating the potential of modified MSCs to treat other conditions, including cancer and announced in 2016 a
partnership with German company Apceth to investigate engineered MSCs in cancer.
LATEST NEWS
Cynata has successfully completed a proof-of-concept studies with its Cymerus™ MSC product in models of critical
limb ischaemia, asthma and in GvHD , in which efficacy was clearly demonstrated, and further proof of concept
studies in models of idiopathic pulmonary fibrosis are ongoing. The company has also completed technology transfer
and scale-up of the Cymerus™ manufacturing process to a GMP-compliant manufacturing facility. Cynata is also
conducting additional programs, one in cardiovascular disease with the University of Sydney and another to develop
modified MSCs to treat cancer, in collaboration with Massachusetts General Hospital/Harvard Medical School. The
Company has also announced a developing strategic alliance with FUJIFILM, a major participant in the regenerative
medicine sector.
CEO: Dr Ross Macdonald
Established in Australia in 2011
ABN: 98 104 037 372
Status: Private
www.cynata.com
CONTACT
Dr Ross Macdonald
P: +61 (0) 412 119343
E: [email protected]
Snapshot of Stem Cell Companies in Australia
10
Mesenchymal Stem
Cells
Regeneus Ltd is an ASX-listed clinical stage regenerative medicine company developing a portfolio
of innovative cellular therapies for the human and animal health markets
Regeneus’ clinical focus is on osteoarthritis (OA), cancer, inflammatory skin conditions and wound care.
The company’s product pipeline is underpinned by proprietary stem cell and immunotherapy technologies
comprising:

allogeneic off-the-shelf adipose-derived mesenchymal stem cells (MSCs) for OA and other inflammatory
conditions (Progenza for humans and CryoShot for animals)

allogeneic off-the-shelf bioactive secretions from adipose-derived MSCs for inflammatory skin conditions
and wound care (for humans only)

autologous cancer immunotherapy that uses the patient’s tumour cells and a bacterial adjuvant for
immune recognition (RGSH4K for humans and Kvax for animals)
MSCs respond to the local disease environment and secrete a diverse variety of bioactive factors including
cytokines and growth factors that are responsible for reducing inflammation, promoting tissue repair and
reducing scarring.
PIPELINE
The company is conducting two Phase 1 human trials: the STEP trial using Progenza to treat OA has completed
recruitment and the pre-specified review of patient safety data showed no safety concerns. The 12 month posttreatment follow-up will be completed in Q3 FY17; the cancer vaccine trial (ACTIVATE) has commenced and
enrolment should be completed in H2 FY17. The company will be conducting clinical studies for its secretions
technology for topical applications.
LATEST NEWS
Regeneus is well advanced in discussions for licensing its Progenza technology for manufacture, development
and commercialization in Japan. Japan has become an active market for partnering of stem cell technologies
and therapies following the introduction in 2014 of regulations that provide an accelerated pathway to bring
new cell therapies to market.
CEO: John Martin
Established in Sydney, Australia in 2007
ABN 13 127 035 358
Status: Public (ASX: RGS)
www.regeneus.com.au
CONTACT
Sandra McIntosh | Investor Relations
P: +61 2 9499 8010
Snapshot of Stem Cell Companies in Australia
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Biobanking
Cell Care is Australia’s largest and most experienced cord blood and tissue stem cell bank. We collect process and
store umbilical cord blood and tissue to provide potential medical treatment options for Australian families.
Cell Care is Australia’s largest and most experienced cord blood and tissue bank. Cell Care has recently acquired
Insception Lifebank, Canada’s largest private cord blood & tissue bank. The combined entity creates one of the
world’s top 10 companies in the sector. Together, we store over 100,000 client samples and establish a global
platform to expand its clinical trial initiatives into North America that may potentially include cord blood
investigations in cerebral palsy and type-1 diabetes.. Cell Care operates according to the highest level of quality
management systems and is regulated for storage and release by the Therapeutic Goods Administration. All of
Cell Care’s processes are structured according to, and aligned with the Australian code of Good Manufacturing
Practice (cGMP) and the Foundation of Accredited Cellular Therapies standard (FACT/ Netcord). Our facility is
located in Melbourne. Whilst we collect cord blood from virtually all maternity hospitals in Australia, the main
challenge for the business is to drive awareness and uptake of cord blood banking with only 1-2% of all births in
Australia storing privately. We invest in driving market awareness through multiple consumer and health care
professional channels. We manage our own national network of up to 100 cord blood collectors and own the
entire value chain from marketing to collections, laboratory processing, storage and release (transport
excluded). We are experiencing strong growth and have high levels of expertise across all areas of the business.
CLINICAL TRIAL NEWS
Our research investment program supports pre-clinical and clinical local Australian research investigating
methods to improve clinical outcomes for approved and potential new indications for cord blood therapy.
In June 2015 Cell Care received national TV and print news coverage when a four-year Perth girl became the first
person worldwide to receive her own cord blood (stored at Cell Care since birth) in a clinical trial investigating
the safety and efficacy of cord blood to prevent or delay the onset of type 1 diabetes. This study, being run by
Sydney’s Kids Research Institute at the Children’s Hospital Westmead is funded by Cell Care and aims to screen
400-600 high risk type 1 diabetes children with the aim of 20 reinfusions in the next 3 years.
LATEST NEWS
Cell Care in partnership with the Cerebral Palsy Alliance, is funding a second clinical trial investigating the
potential of sibling cord blood to treat children with cerebral palsy. The study, sponsored by the Murdoch
Childrens Research Institute in Melbourne, received governance and ethics approval in August 2016 from the
Royal Children’s Hospital and is currently screening up to 48 children with the aim of infusing 12 children with
Cerebral Palsy with fully matched sibling cord blood. This study is Australia’s first cell therapy clinical trial for
cerebral palsy, and will add valuable insight to the already growing data investigating the safety and efficacy of
cord blood in this setting, and further explores the possibility that sibling (related) cord blood delivers better
outcomes than non-related donors. The above clinical study is being extended by collaboration between Cell
Care and The Ritchie Centre, at the Hudson Institute of Medical Research exploring the expansion of
neurotrophic factors from umbilical cord blood cells for the treatment of neurological disorders. This study
received funding from The Science and Industry Endowment Fund (SIEF) in June 2016 for a three year period.
CEO: Brent Dennison
Established in Australia in 2003
ABN: 35 110 312 537
Status: Private
www.cellcare.com.au
CONTACT
Brent Dennison
+61 (03) 8551 0200
[email protected]
Snapshot of Stem Cell Companies in Australia
12
Biotechnology
Calimmune is accelerating the promise of gene therapy to liberate patients from chronic
and currently incurable diseases. To achieve our ambitious goal, we have built a suite of
technologies to advance the delivery, manufacturing, and overall efficiency of these lifechanging medicines. Calimmune’s lead development programs are novel ex-vivo gene
therapies for hematologic diseases.
CEO: Mr Louis Breton
Established in Australia
as Calimmune Australia Pty Ltd in 2009
ABN: 86 134 900 397
Status: Private
www.calimmune.com
CONTACT
Hailee Jones | Administrative Manager
P: +61 (02) 8382 4921
E: [email protected]
Snapshot of Stem Cell Companies in Australia
13
Biotechnology
Genea Biocells is a neuromuscular disease-focused discovery stage company using proprietary human pluripotent stem cell technologies. Genea Biocells also provides contract research services to pharma and supplies reagents to strategic academic collaborators to expand their capabilities and further validate their technologies.
Genea Biocells has one of the world’s largest banks of pluripotent human embryonic stem cells and developed
the world’s first consistent, scalable and high-yield differentiation process for functional skeletal muscle cells.
Genea Biocells is based in San Diego, California and is part of the Australian Genea group, a public, unlisted
company that has been operating world leading IVF clinics since 1985. The company has been supplying commercial stem cell solutions for 10 years, drawing on an almost 30 year research heritage within Genea.
PIPELINE
Genea Biocells’ lead programs are (1) small molecule modulators of FSH muscular dystrophy, one of the most
common genetic muscle disorders, and (2) stem cell-derived satellite cells for cell therapy.
LATEST NEWS
Californian/Australian drug discovery company Genea Biocells has demonstrated and described the world’s
first human stem cell-based cellular model for a muscular dystrophy that is suitable for high-throughput
screening and drug development. In research published in Stem Cells Translational Medicine, scientists from
Genea Biocells analyzed in detail cellular and molecular aspects of facioscapulohumeral muscular dystrophy
(FSHD) during myogenic development and in myotube cultures by comparing muscle cells generated from five
FSHD-affected and four normal control stem cell lines. Facioscapulohumeral Dystrophy (FSHD) is an inheritable
muscle disease affecting approximately 1 in 8,000 people. There is no cure or treatment strategy for patients
with FSHD. The findings highlight Genea Biocells’ efficient and highly scalable monolayer system to differentiate human pluripotent stem cells into skeletal muscle cells and demonstrate disease-specific phenotypes in
muscle derived from both human embryonic and induced pluripotent stem cells affected with FSHD.
CEO: Dr Tomas Stojanov
Established in Australia in 2013
ABN: 68 074 369 038
Status: Private
www.geneabiocells.com
CONTACT
Dr Uli Schmidt | General Manager
P: +61 (02) 8484 6510
E: [email protected]
Snapshot of Stem Cell Companies in Australia
14
Manufacturing and
Medical Devices
Orthocell Ltd is an Australian regenerative medicine company dedicated to the development and commercialisation of
an important new class of autologous cellular therapies and collagen scaffolds for the treatment of human tendons,
ligaments and soft tissue defects.
Development to date has focused on two main products: ‘Autologous Tenocyte Implantation’ (“ATI”) and the
biological reconstruction scaffold ‘Celgro™’. Orthocell has achieved significant development milestones to date
including a licence from the Therapeutic Goods Administration (TGA) to manufacture human tissue in its whollyowned, state of the art facility. This facility has enabled the company to commercialise ATI and manufacture its
biological reconstructive scaffold Celgro™. Orthocell’s technologies have now been substantially de-risked; its target
markets are large and growing; its products and procedures are regarded by key opinion leaders as being superior to
existing therapies
PIPELINE
Orthocell is focused on the 3 key areas of regenerative medicine in the musculoskeletal space. Cells, growth factors,
and scaffolds form the core of Orthocell’s pipeline opportunities with strong preclinical data supporting the concept
of tissue specific growth factor production, a solid pipeline of scaffold opportunities across a multiple specialities and
applications and continued work on ligament and tendon replacement technologies incorporating both cellular and
scaffold aspects.
LATEST NEWS
 The Company partnered in the receipt of an Australian Research Council (ARC) grant of $430,000 to further
investigate tendon tissue and develop novel therapies such as the laboratory fabricated tendon project announced
by Orthocell in November 2014.
 The announcement of the Company’s innovative cell factory derived proteins pipeline product was further
validated following the publication of data from a collaborative research project involving centres in Sweden,
Australia and India. The paper was published in the leading scientific publication Journal of Tissue Engineering and
Regenerative Medicine and provides peer reviewed support for a new approach to regeneration of damaged
cartilage within joints which is highly complementary to Orthocell’s current Ortho-ACITM cartilage repair product;
 The Company held its inaugural user group meeting in Sydney. Attendees included 40 leading orthopaedic
surgeons, sports physicians, radiologists, physiotherapists and pain clinicians from Australia and New Zealand. The
meeting brought together some of Australia’s leading doctors to discuss their experiences with The positive
experiences and clinical outcomes presented further demonstrated that Ortho-ATITM technology is a safe and
effective treatment for degenerate tendons; and
 The presentation by Orthocell’s collaborators of its successful ‘cell factory’ data at the European Bone and Joint
Infection Society in Estoril Portugal September 2015. The data was generated as a result successful collaboration
with institutes in Sweden, Australia, Denmark, India and UK and has supported the role of growth factors and
extracellular matrix proteins which were derived by the researchers from bone cells cultivated in a cell factory, to
be combined with scaffolds, to regenerate serious bone defects .
CEO: Paul Anderson
Established in Australia in 2006
ABN: 57 118 897 135
Status: Public
www.orthocell.com.au
CONTACT
Paul Anderson
P: +61 411 861 626
[email protected]
Snapshot of Stem Cell Companies in Australia
15
Manufacturing
Cell Therapies is leading in cGMP manufacture and distribution of cellular therapies in Asia Pacific. We provide the
essential deployment infrastructure for the safe, reliable and scalable delivery of cellular therapies into clinical
trials and for therapeutic use.
Cell Therapies is leading in cGMP manufacture and distribution of cellular therapies in Asia Pacific. We provide
the essential deployment infrastructure for the safe, reliable and scalable delivery of cellular therapies into clinical trials and for therapeutic use in a region of more than 750 million people. Playing a pivotal role in the cellular
therapy value chain, we are poised to deliver essential capability to, and capture significant value from, a sector
now delivering transformative health outcomes. For over a decade, Cell Therapies has operated TGA regulated
cell processing facilities from our home at Peter MacCallum Cancer Institute and made these facilities available
on a fee-for-service basis to some of the world’s leading cellular therapies companies. We have successfully
helped develop products and processes that are compliant with global regulatory and cGMP requirements and
have successfully integrated with global manufacturing networks. This capability is in short supply as cellular therapy products reach maturity.
Cell Therapies is expanding its deployment network with a strategic alliance with PharmaBio in Japan. We have
also added an apheresis site management service line to provide control over this critical starting material.
We can now offer a single gateway to Asia to customers at translational research through commercial launch
scale.
PIPELINE
Cell Therapies has broad experience manufacturing and delivering a wide range of cellular therapy products, generated from a wide range of tissue types, with a wide range of cell processing techniques and in a wide range of
indications. Our expertise is deepest in autologous therapies in the areas of gene therapies, gene-modified immunotherapies (eg CAR-T), immunotherapies (eg DC vaccines), regenerative medicine and apheresis.
LATEST NEWS
Recent highlights at Cell Therapies include:
Entering a strategic alliance with PharmaBio of Japan to create a joint business development collaboration under
a harmonised quality system
Opening our new 10 clean room GMP cell processing facility at the new home of Peter Mac, the VCCC Building in
Melbourne's Parkville precinct. This doubles our capacity in Melbourne and is the template for a new facility
PharmaBio is constructing in Japan.
CEO: Tim Oldham, PhD
Established in Australia in 2003
ABN: 15 100 285 916
Status: Private
www.celltherapies.com.au
CONTACT
Cell Therapies Pty Ltd
P: +61 3 8559 7310
E: [email protected]
Snapshot of Stem Cell Companies in Australia
16
Medical Devices
Avita Medical develops and distributes regenerative products for the treatment of a broad range of burns,
wounds, scars and skin defects. Avita’s patented and proprietary collection and application technology provides
innovative treatment solutions derived from a patient’s own skin.
Avita’s lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic
procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the
United States, ReCell® is an investigational device limited by federal law to investigational use.
ABOUT RECELL®, REGENERCELL®. RENOVACELL®, AND RES™
ReCell® is Avita Medical’s unique proprietary technology that enables a clinician to rapidly create, at point of care in
approximately 30 minutes, Regenerative Epithelial Suspension (RES™) using a small sample of the patient’s skin. RES™ is an
autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin. RES™
has a broad range of applications and can be used to restart healing in unresponsive wounds, to repair burns using less
donor skin yet with improved functional and aesthetic outcomes, and to restore pigmentation and improve cosmesis of
damaged skin.
PIPELINE
Product derivatives to meet new clinical indications, including chronic wounds such as Diabetic Foot Ulcers and Venous Leg
Ulcers.
LATEST NEWS
Business

Awarded a contract with BARDA for up to US$53.9m

Received CE Mark for ReGenerCell and ReNovaCell – product derivatives

Entered into a research partnership with University of Huddersfield

Received patent validation in 11 European countries

International rollout of proposition with distributor appointments in 12 territories, including China

Strengthened Board and management positions to accelerate commercialisation

A data-driven commercial execution strategy, with clear milestones, to make the approach mainstream

Value creation is the main commercial focus of the management team
Clinical

Publication in the Journal of Cranio-Maxillo-Facial Surgery of results from a series of cases using ReCell® show
clinically significant improvements in aesthetic outcomes

First patient treated in investigator-initiated trauma wound trial at Walter Reed National Military Medical Center

FDA-approval of expanded Compassionate Use Investigational Device Exemption (IDE) program for ReCell® to
continue clinical evaluation on twice as many patients as originally permitted

Presentation of three academic papers at the 16th European Burns Association Congress that further demonstrate
ReCell®’s effectiveness

Extensive data package that includes more than 60 publications

Recent RCTs in chronic wounds and repigmentation show significance

FDA burns trial fully recruited, and on track for PMA pathway submission: approval expected Q3 2017

Randomized, multi-centre venous
CEO: Adam Kelliher
Established in Australia in 1993
ABN: 28 058 466 523
Status: Public
www.avitamedical.com
CONTACT
Lorraine Glover| General Manager, Asia Pacific
P: +61(08) 9474 7738
E: [email protected]
Snapshot of Stem Cell Companies in Australia
17
Overseas Stem Cell Companies
with branches in Australia
Snapshot of Stem Cell Companies in Australia
18
Biotechnology
Cytomatrix was formed in 2007 to develop a series of technologies licensed in from Cordlife Ltd (a foundation
shareholder), Barwon Health and Deakin University. This led, in 2014, to the formation of HeiQ Australia, a Joint
Venture with Swiss chemical company HeiQ AG, to develop a world leading technology for the manufacture of short
nanofibres, and in 2015 to the formation of Nohla Therapeutics Inc, a US-based company that has licensed in seven
patent families in the field of haematopoietic stem cell expansion from the Fred Hutchinson Cancer Research Centre.
When combined with Cytomatrix’s own technologies in the field of stem cell expansion, we believe that Nohla
Therapeutics Inc. will rapidly become a world leader in the field of cell therapies.
Cytomatrix Ltd holds assets in HeiQ Australia and HeiQ AG, as well as retaining all rights to the development of
biomedical applications of short nanofibres. The Cytomatrix management team has shown an exceptional ability to
realize the full potential of its technologies through a series of transactions through 2014 and 2015 which have
increased shareholder value more than seven fold in 18 months. We anticipate significant potential for further
commercialization of short nanofibres in the fields of wound healing, tissue engineering, coagulation, diagnostic and
many others, leveraging established and highly productive R&D relationships with Deakin and Monash Universities.
PIPELINE
Cytomatrix is currently reconfiguring its business plan following successful sale of its stem cell assets to Nohla
Therapeutics Inc. Utilizing existing grant opportunities through the innovative Manufacturing CRC and the Industry
Transformation Research Hub, together with proceeds from the sale, Cytomatrix Ltd will accelerate development of
key platform applications of short nanofibres in wound healing, artificial skin, slow release of drugs and modulation of
coagulation.
LATEST NEWS
In November 2014 Cytomatrix Ltd entered into a Joint Venture Agreement with Swiss company, HeiQ AG, to develop
the Cytomatrix short nanofibre technology. Under this Agreement, a joint venture company, HeiQ Australia, was
formed to develop manufacturing capabilities for short nanofibres. HeiQ AG retained a license for applications of these
fibres in the fields of textiles and coatings, with Cytomatrix Ltd retained a license for all biomedical applications.
In September 2015 Cytomatrix created a new US company, Nohla Therapeutics Inc (“NTI”), with mirrored shareholding,
and in October 2015 CTI signed an agreement with Fred Hutchinson Cancer Research Center (FHCRC) in Settle,
Washington, to license seven patent families in the field of haematopoietic stem cell expansion and related
technologies. FHCRC is a world leader in bone marrow transplantation, and developed the first successful cord blood
stem cell expan-sion technology (Nature Medicine, 2010, 16(2):232-6). NTI has licensed this technology, together with
new patents in the field of chimeric antigen receptors and NK-cell therapeutics. In November 2015, Cytomatrix Ltd.
sold its stem cell technologies (a novel expansion agent, Ficolin, and 3D cell culture technologies) to NTI.
CEO: Ben Bergo
Established in Australia in 2007
ABN: 109 903 737
Status: Public unlisted
www.cytomatrix.com.au
CONTACT
Mark Kirkland | Chief Scientific Officer
P: +61 408 395 012
[email protected]
Snapshot of Stem Cell Companies in Australia
19
Medical Devices
Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. We believe
in the potential of blood to do even more for patients than it does today.
Whether your company is a start-up or well established, taking a new biological product or cellular therapy from
laboratory to market requires a scalable process. Terumo BCT's cell culture technology offers the scalability and
automation these go-to-market projects demand. Addressing this need early—establishing a scalable and
efficient process in the pre-clinical stage of development—protects the commercial viability of your projects.
What's more, adopting scalable processes early may eliminate the need to revalidate or revisit your
manufacturing processes later. Terumo BCT also delivers technologies for secondary cell processing and
dependable tools for maintaining sterility—solutions that support you in developing cell therapies that may
fundamentally improve health care.
PIPELINE
Terumo BCT has a proven history of long-term, sustainable, profitable growth, driven by our innovation pipeline.
We invest over $70 million USD in Research and Development, or what we call “Innovation & Development,” per
year. We pride ourselves on continuous improvement and are always looking for ways to keep pace with the
changing landscape of the industry and the needs of our hospitals, blood centers, laboratories and the donors
and patients we serve.
LATEST NEWS
Athersys, Inc., a biopharmaceutical company, evaluated the use of the Quantum® Cell Expansion
System from Terumo BCT as a manufacturing platform for producing Multipotent Adult Progenitor Cells (MAPC®),
an adherent stem cell product. The combined yield of 10 Quantum systems consistently delivered batches of
more than 9 billion cells that met all safety and quality criteria established for the study. Additionally, results
demonstrated a 40 percent cost savings relative to Athersys' current process.
CEO: David B. Perez
Established in Lakewood, Colorado, USA
Terumo BCT Australia, 2012
ABN: 130 046 865
Status: Terumo BCT Australia is a subsidiary of
Terumo BCT, Inc. (Public Company)
www.terumobct.com
CONTACT
Julia Wenner, PhD | Managing Director
P: +61 (02) 9429 3600
E: [email protected]
Snapshot of Stem Cell Companies in Australia
20
Laboratory Supply Companies
ABN 82 005 914 79
Lewis Cox | Account Manager
P: 1800 656 100
[email protected]
www.bdbiosciences.com/anz
BD is a global medical technology company that is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. BD Life Sciences provides products for the safe collection and
transport of diagnostics specimens, and instruments and reagent systems to detect a broad range of infectious
diseases, healthcare-associated infections (“HAIs”) and cancers. In addition, BD Life Sciences produces research
and clinical tools that facilitate the study of cells, and the components of cells, to gain a better understanding
of normal and disease processes. That information is used to aid the discovery and development of new drugs
and vaccines, and to improve the diagnosis and management of diseases. The primary customers served by BD
Life Sciences are hospitals, laboratories and clinics; blood banks; healthcare workers; public health agencies;
physicians’ office practices; academic and government institutions; and pharmaceutical and biotechnology
companies. BD Life Sciences consists of the following business units: Preanalytical Systems, Diagnostic Systems
and Biosciences. The principal product lines in the Biosciences business unit include: Fluorescence-activated
cell sorters and analyzers; monoclonal antibodies and kits for performing cell analysis; reagent systems for life
science research; molecular indexing and next-generation sequencing sample preparation for genomics
research; clinical oncology, immunological (HIV) and transplantation diagnostic/monitoring reagents and
analysers; and cell culture media supplements for biopharmaceutical manufacturing.
ABN: 11 001 405 947
Technical enquiries
Daryn Metti – [email protected]
Pricing and placing orders [email protected]
P: 1300 BIOSCI (246724)
www.biosci.com.au
Bio-Scientific Pty. Ltd., was established in 1972 as a general Laboratory Supply Company providing superior
and sought after products to Life Science Research facilities throughout Australia. The Company’s primary focus
and objective is providing quality service. Quality Technical support is of the most important functions of the
service we provide to the market. In addition, all aspects of Customer service are continually upgraded and
improved to address our commitment to Service. Our allegiances with the best logistics companies, our
connections within all facets of the regulatory divisions of state and federal bodies and the knowledge and
expertise within the life science world, we now move forward to a brighter future with you our loyal
customers. One aspect that separates Bio-Scientific from its competitors is that we will at-tempt to source
products for our customers from non-represented suppliers. We also believe it is essential to respond
immediately to orders for non-stocked items.
Listed below are some agencies that provide products suitable for Stem Cell research: a) Trevigen; b)
ReproCELL; c) Jena BioScience; d) Empire Genomics; e) ACRObiosystems; f) Genlantis; g) Celartia; h)
Humanzyme; i) Synaptic Systems; j) VLVbio plus others.
Snapshot of Stem Cell Companies in Australia
21
ABN: 20 008 265 969
Andrew Masters | Managing Director
P: 0439 819 095
[email protected]
www.coherent.com.au
Coherent Scientific is a specialist supplier of scientific instrumentation to Australasia, exclusively representing
Nikon Instruments, Bruker, Coherent Inc, Andor and many other premium vendors. We have supported the
scientific community in Australia and New Zealand for over 26 years with expert sales & service teams in every
major capital city.
Stem Cell Imaging & Analysis
Nikon’s BioStation IM-Q is a self-contained & self-regulated incubator with phase + fluorescence imaging
designed for studies of cell growth, morphology and protein expression. The BioStation CT is a similar but larger
capacity imaging system, capable of handling up to 30 different vessels ranging from well plates to culture
flasks in a robotised & fully automated incubator.
BioStation systems are compatible with Nikon’s powerful high content analysis software (HCA) allowing
multiple assays to be run simultaneously, drastically cutting down the time to data in post-acquisition analysis.
Plate heat maps, images, generated binary masks, assay results, sample labelling and other metadata are
centralised for quick filtering, gating and drill down to cellular detail.
ABN: 27 086 564 678
Monica Santese
Product Manager | Cell and Sample Handling
[email protected]
www.eppendorf.com.au
Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for
Liquid, Sample and Cell handling in laboratories worldwide.
Eppendorf’s product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers,
spectrophotometers and DNA amplification equipment as well as ultra-low temperature freezers, platform and
incubator shakers, CO2 Incubators, Bioprocess equipment and cell manipulation systems. Associated
consumables like pipette tips, centrifuge tubes, microtiter plates, cell culture consumables and disposable
bioreactors vessels complement the instruments for the highest quality workflow solutions.
Our mission is to be a synonym for customer-focused processes, innovative technologies, premium products
and services to improve human living conditions.
Snapshot of Stem Cell Companies in Australia
22
ABN: 27 102 379 895
Daina Elliott
Sales Manager
P: 1300 552 003
[email protected]
www.invitro.com.au
In Vitro Technologies specialises in the sales, marketing, distribution and support of quality
products, systems and tools to the medical, diagnostics, life sciences and industrial sectors
throughout Australia and New Zealand. In Vitro Technologies presents a premium portfolio of
products for the various aspects of Stem Cell research and therapeutic development, comprising the highest
quality reagents, equipment and consumables from around the world. Expansion and
differentiation (Stem cell lines - ATCC; Complete stem cell media - R&D Systems; Cytokines and growth factors
including GMP proteins - R&D Systems; Serum and base media - HyClone; Falcon Cell Culture Plastic ware and
ECM - Corning life Sciences). Verification (Antibodies and stem cell verification kits - R&D Systems; Flow
Cytometers - ACEA Biosciences). Investigation (Real-time cell analysers and flow cytometers - ACEA
Biosciences; Real-time metabolism analysers - Seahorse Biosciences). Laboratory Equipment (Cryogenic Storage
Solutions - Taylor-Wharton; Cell culture scale up solutions - Infors; Biological Safety Cabinets, Incubators and
ULT Freezers - NuAire).
ABN: 95 111 167 858
Lisa Neville
Office Manager
P: 1300 657 508
[email protected]
www.lonza.com
Lonza is one of the world’s leading and most trusted suppliers to the pharmaceutical, biotech and specialty
ingredients markets. We harness science and technology to create products that support safer and healthier
living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from
active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B
compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to
microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major
manufacturing and R&D facilities and approximately 9,800 employees worldwide. The company generated
sales of about CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech
and Specialty Ingredients. Lonza’s stock is publicly traded on the Swiss and the Singapore stock exchanges.
Further information can be found at www.lonza.com.
Lonza Australia supplies to researchers adult stem cells and media, growth factors and cytokines from
PeproTech, primary cells and media, Nucleofector™ non-viral transfection technology and the MycoAlert™
Mycoplasma Detection System.
Snapshot of Stem Cell Companies in Australia
23
ABN 80 001 239 818
Debbie Stanley
Marketing Manager
P: 1800 335 571
[email protected]
www.merckmillipore.com
Merck Millipore is the Life Science business of Merck, providing innovative tools and laboratory
supplies for the life science industry that make research and biotech production easier, faster and more
successful.
In Australia Merck Millipore is headquartered in Bayswater, VIC with specialist life science sales and support
teams in most states. Merck Millipore is deeply committed to providing novel cell culture
systems and characterization tools for stem cell research and primary cell culture.
Our highly
validated, optimized products provide convenient solutions to many cell culture challenges, so you have time
to focus on your research goals.
Merck Millipore offers a comprehensive line of stem cell products including human and murine stem cells,
media optimized for stem cell and primary cell culture, growth factors, exclusive antibodies,
cultureware, and kits to help you jump start your research.
For process development, pilot and clinical scale the range includes single-use bioreactors, optimized cell
culture media formulations and cell culture clarification solutions.
The Stem Cell Research section of our website offers a unique learning centre where you can easily find newly
released products, detailed protocols, latest stem cell news, and user-friendly guides to our specialty cell
culture products.
ABN: 62 100 017 105
Dr. Hermann Bohnenkamp
Managing Director
Phone +61 0405 399 959
[email protected]
www.miltenyibiotec.com
Miltenyi Biotec is one of the world’s leading providers of products and services for biomedical research as well
as cell and gene therapy.
MACS® Technology is the gold standard in magnetic cell separation. We offer complete workflow solutions
from sample preparation to cell separation, media and cytokines for cell culture, flow cytometry and small animal pre-clinical imaging. Miltenyi Biotec provides expert technical advice and actively participates in research in
a wide range of scientific fields including, among other; immunology, cancer, stem cells and neuroscience. We
offer GMP cellular therapeutic products and are committed to the promise of cellular medicine in the fields of
organ regeneration, immune modulation and transplantation.
Within the stem cell field, our activities address mesenchymal, hematopoietic and cancer stem cells. By developing protocols for GMP-compliant cell separation, differentiation, expansion and formulation, we have been
able to sponsor a multicenter phase III clinical trial of CD133-positive hematopoietic cell grafting during CABG
surgery and its role in improving post-infarct myocardial regeneration. Currently, our emphasis is on developing
great tools for the isolation, analysis, and culture of embryonic stem cells, induced pluripotent stem cells, tissue
(e.g. neural, cardiac and hepatic) stem cells and cancer stem cells. Our latest developments focus on reprogramming, directed differentiation and enrichment of the resulting differentiated cells.
The company is committed to enabling the delivery of new treatment options to patients with unmet medical
need. Miltenyi Biotec’s portfolio of innovative solutions and enabling technologies have set new standards in
the industry. The company has more than 1,600 employees in 25 countries and its products have been used in
more than 50,000 cell therapy procedures. For more information please visit www.miltenyibiotec.com.
Snapshot of Stem Cell Companies in Australia
24
PreproTech operates in Australia via a distributor*
Mr. Offir Manor | General Manager, PeproTech Asia
[email protected]
www.peprotech.com
Supporting life science research since 1988, PeproTech has a long record of being a trusted manufacturer of
high quality cytokine products for the life-science and cell therapy markets.
Since the beginning of stem cell research, a significant part of PeproTech's activity has been focused on this
field, offering hundreds of relevant products. PeproTech is continually positioned among the top two cited
suppliers in the most prestigious scientific journals in the field, with over 5000 citations each year.
With over 2,000 products, PeproTech has developed and refined innovative production and purification
protocols to ensure the quality, reliability and consistency of its products. Our mission is to provide the highest
quality products and premium support and customer service that address the needs and requirements of
today’s scientific community and the growing landscape of cellular therapy oriented companies. We pride
ourselves on being a trusted partner within the basic and applied scientific research community.

Research Use Only (RUO) proteins and antibodies

GMP-Compliant products for Cell, Gene and Tissue Therapy

A wide range of Animal Free recombinant Cytokines

ELISA kits

Stem Cell Culture Media and Kits

Small molecules for stem cell research

Antibodies and Reagents for Flow cytometry
*PeproTech is distributed in Australia by LONZA and in New Zealand directly with an Office in Australia managed by Margret Schuller
ABN: 60 055 311 236
P: +61 2 9698 2022
[email protected]
www.sapphirebioscience.com
Sapphire Bioscience distributes over 800,000 research products from over 80 suppliers including Cayman
Chemical, Enzo Life Sciences , AdipoGen, Selleck Chem, Abnova and GeneTex. Sapphire Bioscience aims to
provide
Australian
and
New
Zealand
Stem
Cell
Researchers
with
superior
quality antibodies, biochemicals, small molecules, cytokines, growth factors, cell lysates, ELISA kits, multiplex
kits, assay kits, proteins, tissue slides and more.
Snapshot of Stem Cell Companies in Australia
25
ABN: 81 083 311 853
Dr Nikki Tsoudis
Director | Lab Products Specialist
[email protected]
www.scientifix.com.au
http://www.clontech.com/AU/Products/Stem_Cell_Research
Scientifix Pty Ltd is an Australian-owned private company offering innovative research tools and equipment for
the life science community since 1998. Scientifix Pty Ltd proudly distributes Takara Bio. Takara Bio is committed
to improving the human condition through biotechnology with three primary areas of focus: developing
research tools for the life sciences, gene therapy, and nutraceuticals. Takara has been focusing on biomedical
research since 1967. Takara Bio has positioned itself as a leading company in the Japanese life science market
through the Takara and Clontech brands.
Clontech Laboratories provides kits, reagents, and services that help researchers explore questions about gene
discovery, regulation, and function. As a member of the Takara Bio Group, Clontech is part of a company that
holds a leadership position in the global market and is committed to improving the human condition through
biotechnology. Clontech's mission is to develop high-quality innovative tools and services to accelerate
discovery.
Takara Bio Europe AB, formerly Cellartis AB, a subsidiary of Takara Bio Inc., is focusing on stem cell derived
products and services for drug discovery, toxicity testing, and applications within regenerative medicine. The
company leverages long-standing experience in stem cell handling and scale-up together with leading expertise
in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad
expertise in human pluripotent stem cells, including both hiPSC and hESC and related media.
ABN: 15 128 391 766
Cyndy Nauer
Managing Director Asia Pacific
P: 1 800 060 350
[email protected]
www.stemcell.com
STEMCELL Technologies Inc is a privately-owned biotechnology company that develops specialized cell culture
media, cell separation products and accessory reagents for life science research. Driven by science and a
passion
for
quality,
STEMCELL
delivers
over
1500
products
to
more
than
70
countries worldwide. STEMCELL has been dedicated to providing standardized reagents and tools for all areas of
stem cell research, and has extended this expertise to many other sectors of life
science. The importance of quality control processes and raw material selection is critical to the production and
optimal performance of STEMCELL’s entire portfolio of products, ensuring that batch-to-batch variability is
minimized.
Snapshot of Stem Cell Companies in Australia
26
ABN: 52 058 390917
Naomi Morison
Technical Sales Specialist | Stem Cells
P: 0411 565 128
[email protected]
www.thermofisher.com/stemcells
Thermo Fisher Scientific is the world leader in serving science. For over a decade, we have provided the key
tools and resources you need to address challenges in stem cell research. Our complete portfolio of Invitrogen
and Gibco products and services can support every step of your research and you can benefit from the
continuity, efficiency, and precision that drive discovery.
ABN: 70 145 429 974
Renaud Quantin
Sales Specialist | Life Sciences
P: 0408 870 897
[email protected]
au.vwr.com
VWR International Pty Ltd is a global laboratory supplier for consumables, equipment, chemicals, safety
apparel, life science reagents and services. VWR, formerly Quantum Scientific and Crown Scientific, is
committed to providing the best products with the best service within the Australian scientific community and
industry.
VWR supports BEGINNING-TO-END SOLUTIONS FOR STEM AND PRIMARY CELL RESEARCH through our premium
portfolio from Corning & Falcon, including surfaces for cell expansion, vessels for stem cell culture, advanced
surfaces for cell isolation and derivation, and Matrigel extracellular matrix for stem cell expansion.
At VWR we continue to work with researchers, providing high quality cell culture consumables, as well as
verification tools such as antibodies and ELISA (Bethyl, Abnova and others), transfection reagents (PolyPlus),
and highest quality laboratory equipment (Eppendorf, Panasonic and many others).
With offices in Brisbane, Melbourne and Sydney and Sales Specialists active in all states VWR is well placed to
service its highly valued existing and new clients. For peace of mind, our VWR Technical Service Team provides
a unique combination of service and support for all your equipment.
Snapshot of Stem Cell Companies in Australia
27
Table 1. Details of clinical trials run by cell therapy companies listed in the Snapshot *
Company
Study
identifier
Study title
Phase Comparator
Ethics
approval
Avita
Medical
NCT02458417
Autologous cell suspension grafting using ReCell in
vitiligo and piebaldism patients: a Randomized
Controlled Study on the recipient site preparation
4
Control: no
intervention
No details
available
Avita
Medical
NCT01640678
Autologous cell suspension grafting using ReCell in
vitiligo and piebaldism patients: a Randomized
Controlled Pilot Study
4
Active
comparator:
laser and UV
or UV only
No details
available
Avita
Medical
NCT02799121
A feasibility study of the ReGenerCell™ autologous
cell harvesting device for diabetic foot ulcers
4
Uncontrolled
No details
available
N/A
Withinsubject
control
No details
available
4
Standard care
No details
available
1/2
Uncontrolled
No details
available
N/A
No details
available
Demonstration of the safety and effectiveness of
ReCell® combined with meshed skin graft for
NCT02380612
reduction of donor area in the treatment of acute
burn injuries
Avita
A Pilot Trial of the use of ReCell® autologous cell
NCT01743053
Medical
harvesting device for venous leg ulcers
An adaptive phase I/II study of the safety of CD4+ T
lymphocytes and CD34+ hematopoietic stem/
progenitor cells transduced with LVsh5/C46, a dual
Calimmune NCT01734850
anti-HIV gene transfer construct, with and without
conditioning with Busulfan in HIV-1 Infected adults
previously exposed to ART
Avita
Medical
Long Term Follow-up for the detection of delayed
adverse events in Recipients of CD4+ T Lymphocytes
Calimmune NCT02390297 and/or CD34+ hematopoietic stem/progenitor cells N/A
transduced with LVsh5/C46, a dual anti-HIV gene
transfer construct
Cell Care
Cell Care
Cynata
Mesoblast
Mesoblast
Approved by
the Sydney
ACTRN1261300 A pilot study to assess the feasibility of reinfusion of
Children's
0 Uncontrolled
0186752
cord blood in children at risk of type 1 diabetes.
Hospitals
Network
HREC
Approved by
the Royal
ACTRN1261600 Safety study of sibling cord blood cell infusion to
N/A Uncontrolled Children's
0403437
children with cerebral palsy
Hospital
HREC
An Open-Label Phase 1 Study to Investigate the
CYP-GvHD-P1- Safety and Efficacy of CYP-001 for the Treatment of
No details
1
N/A
01
Adults With Steroid-Resistant Acute Graft Versus
available
Host Disease
The Purpose of This Study is to Evaluate the Efficacy
Sham
and Safety of Allogeneic Mesenchymal Precursor
comparator: No details
NCT02032004
3
Cells (CEP-41750) for the Treatment of Chronic Heart
control
available
Failure
treatment
Sham
Safety & efficacy of intramyocardial injection of
comparator: No details
NCT02362646 mesenchymal precursor cells on myocardial function 2
control
available
in LVAD recipients
solution
* Clinical trial registries (clinicaltrials.gov, anzctr.org.au) were accessed between 1/6/16 and 17/6/16. This is not an
exhaustive list of studies. HREC: Human Ethics Research Committee; MPC(s): mesenchymal progenitor cell(s); MSC
(s): mesenchymal stem cell(s); N/A: not applicable.
Snapshot of Stem Cell Companies in Australia
28
Table 1 (Continued). Details of clinical trials run by cell therapy companies listed in the Snapshot *
Company
Study
identifier
Mesoblast NCT01781390
Mesoblast NCT02412735
Mesoblast NCT02336230
Mesoblast NCT01854567
Mesoblast NCT01851070
Mesoblast NCT01843387
Study title
Safety study of allogeneic mesenchymal precursor
cell infusion in myoCardial infarction (AMICI)
Safety and efficacy study of Rexlemestrocel-L in
subjects with chronic discogenic lumbar back pain
(MSB-DR003)
A Prospective Study of Remestemcel-L, Ex-vivo
Cultured Adult Human Mesenchymal Stromal Cells,
for the Treatment of Pediatric patients Who Have
Failed to Respond to Steroid Treatment for Acute
GVHD
P3 Study of Umbilical Cord Blood Cells Expanded
with MPCs for Transplantation in patients with
Hematologic Malignancies
A Multi-center Study a Single IV Infusion of
Allogeneic MPCs in patients with Rheumatoid
Arthritis and Incomplete Response to at Least One
TNF Alpha Inhibitor
A Randomized, Controlled, Dose-Escalation Pilot
Study to Assess the Safety and Efficacy of a Single
Intravenous Infusion of Allogeneic Mesenchymal
Precursor Cells (MPCs) in Subjects with Diabetic
Nephropathy and Type 2 Diabetes
A Phase III, Multicenter, Placebo-controlled,
Randomized, Double-blind Study to Evaluate the
Safety and Efficacy of PROCHYMAL® (ex Vivo
Mesoblast NCT00482092 Cultured Adult Human Mesenchymal Stem Cells)
Intravenous Infusion for the Induction of Remission
in Subjects Experiencing Treatment-refractory
Moderate-to-severe Crohn's Disease
Single-centre, open-label, pilot study of Celgro(tm)
ACTRN1261500 collagen membrane for guided bone regeneration
Orthocell
0027516
around exposed dental implants in patients
undergoing dental implant surgery
Phase Comparator
2
Placebo
No details
available
3
Placebo
No details
available
3
N/A
No details
available
3
Active
comparator:
Control
No details
available
2
Placebo
No details
available
1/2
Placebo
No details
available
3
Placebo
No details
available
Approved by
St John of
N/A Uncontrolled
God Health
Care HREC
Approved by
South
Metropolita
Uncontrolled
n Health
Service
HREC
ACTRN1261400
0532606
Repair of Symptomatic Ear Drum Perforations: A
Pilot Study using Celgro Trademark Type I/III
Collagen Bioscaffold
1/2
ACTRN1261200
Orthocell
0383864
Patients with gluteal tendinopathy who undergo
autologous tenocyte implantation will have
improved clinical and radiological outcomes at
3,6,12 and 24 months post injection
N/A Uncontrolled
Orthocell
Ethics
approval
Not yet
submitted
* Clinical trial registries (clinicaltrials.gov, anzctr.org.au) were accessed between 1/6/16 and 17/6/16. This is not an
exhaustive list of studies. HREC: Human Ethics Research Committee; MPC(s): mesenchymal progenitor cell(s); MSC
(s): mesenchymal stem cell(s); N/A: not applicable.
Snapshot of Stem Cell Companies in Australia
29
Table 1 (Continued) . Details of clinical trials run by cell therapy companies listed in the Snapshot*
Company
Orthocell
Study
identifier
ACTRN1260700
0402448
Study title
Autologous Tenocytes Therapy to Improve the
Healing Process of Tennis Elbow
The value of Autologous Tenocyte Implantation in
EUCTR2010patients with chronic Achilles tendinopathy: a
Orthocell
021869-73-NL double-blind randomised clinical trial - ATI in Achilles
tendinopathy
In patients with advanced solid tumours, is an
ACTRN1261500
autologous cancer vaccine (RGSH4K), safe and
Regeneus
0516583
tolerable, and can a biologically active dose be
identified?
Patients with solid tumours that are accessible can
bank their tumours in a dedicated tumour bank for
ACTRN1261500
Regeneus
long term fresh frozen storage conditions for the
0476538
possible future production of an autologous cancer
vaccine, the latter being a separate study.
Phase Comparator
1/2
No details
available
1
Uncontrolled
Approved by
Bellberry Ltd
N/A
N/A
Approved by
Bellberry
HREC
Placebo
Approved by
Bellberry
HREC
N/A
Approved by
Bellberry Ltd
Placebo
Approved by
Hawkesbury
HREC of
Northern
Sydney
Central
Coast Health
Platelets
stored in
plasma
No details
available
A Randomised Double Blind, Placebo Controlled
ACTRN1261100 Study Of The Efficacy And Safety Of Autologous NonRegeneus
N/A
1046998
Expanded Adipose Derived Stem Cells In The
Treatment Of Knee Osteoarthritis
In-Vitro Study of Platelets Collected on Trima Accel
System and Stored in InterSol Solution
Approved by
Sir Charles
Uncontrolled Gairdner
Hospital
HREC
Placebo
A Phase 1 Randomised, Double Blind, Placebo
Controlled, Single Ascending Dose Study to Evaluate
ACTRN1261500
Regeneus
the Safety, Tolerability and Preliminary Efficacy of
1
0439549
Intra-articular Progenza (PRG) in adults with
Symptomatic Knee Osteoarthritis
A Registry of Autologous Non-Expanded Adipose
ACTRN1261200 Derived Stem Cells (HiQCellTM) in the Treatment of
Regeneus
N/A
0672853
Osteoarthritis to determine prevalence of joint
infections
TerumoBCT NCT02298842
Ethics
approval
N/A
Evaluation of the Performance of Trima Accel®
No details
Version 7.0 Software Enhancements for the
N/A Uncontrolled
available
Collection of Platelets Stored in 100% Plasma
Evaluation of the Performance of Trima Accel®
Version 7.0 Software Enhancements for the
No details
TerumoBCT NCT02754440
N/A Uncontrolled
Collection of Platelets Stored in Platelet Additive
available
Solution
A Multicenter Study to Evaluate Modified Postcount
No details
TerumoBCT NCT02684630 Algorithm Software on the Trima Accel® System in N/A Uncontrolled
available
Volunteer Blood Donors
Inactivation of Whole Blood with Mirasol :
No details
TerumoBCT NCT01907906
Performance in Red Blood Cells in Healthy
1 Uncontrolled
available
Volunteers
* Clinical trial registries (clinicaltrials.gov, anzctr.org.au) were accessed between 1/6/16 and 17/6/16. This is not an
exhaustive list of studies. HREC: Human Ethics Research Committee; MPC(s): mesenchymal progenitor cell(s); MSC
(s): mesenchymal stem cell(s); N/A: not applicable.
TerumoBCT NCT02754492
Snapshot of Stem Cell Companies in Australia
30
Snapshot of Stem Cell Companies in Australia
31