Placenta Donation
Birth Tissue Recovery LLC
Winston-Salem, North Carolina 27103
www.birthtissuerecovery.com
Placenta Donation: History
• Amnion, chorion, and umbilical
cord obtained from human
placentas has been used to treat
wounds since 1910.
• Burns and skin ulcers were treated
during the 1950s and 1960s with
amnion designed as a skin
substitute.
• Since 2004, processed amniotic
membrane
has
become
recognized as an effective
treatment
for
ophthalmic,
diabetic, burn, anti-adhesion,
orthopedic, nerve, and tendon
wound repair.
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
Placenta Donation: Amnion
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
• Human amniotic membrane is the internal lining of the amniotic sac
closest to the developing infant.
• It is approximately 0.02 to 0.50 mm thick, and consists of five layers:
basement membrane and surface layer, connective tissue that attaches
the basement membrane to the compact, fibroblast, and spongy layers.
• The amniotic membrane is essentially avascular.
Placenta Donation: Amnion
A. Histology of amniotic
membrane by H&E staining
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
B. Magnified view from A:
EC: Epithelial cell
BM: Basement membrane
SM: Stromal matrix
Placenta Donation: Amnion
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
• Processed placenta-based products promote epithelialization and
healing while suppressing inflammation, angiogenesis, and scarring.
• These clinical efficacies have been reported in hundreds of publications
for a wide range of indications. These allografts are non-immunogenic
and enhance wound healing via a unique combination of “bio-active”
growth factors inherently present in the tissue.
• The products are used for external and internal applications.
Placenta Donation:
Regulated
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
• Human tissue products that are “minimally manipulated” are regulated
by the FDA, and do not require 510(k) clearance or pre-market approval
(PMA) to enter the market.
Birth Tissue Recovery LLC
•
Birth Tissue Recovery joins a select group of tissue bank facilities across the United States
and abroad that have earned AATB Accreditation.
•
Accreditation follows an intensive nine-month process, including an on-site inspection by a
specially trained AATB inspector. It establishes that the level of medical, technical, and
administrative performance within the facility meets or exceeds the standards set by the
AATB.
•
The AATB was founded in 1976 by a group of doctors and scientists who had started in 1949
the nation’s first tissue bank, the United States Navy Tissue Bank. Today, its Accreditation
Program and its Standards for Tissue Banking are the only such private, industry programs
available in the United States.
•
AATB’s Accreditation procedures are voluntary. BTR sought AATB accreditation because it
verifies BTR’s commitment to quality and demonstrates to the public our dedication to
improving and saving lives by promoting and facilitating the safety, quality, and availability of
donated human tissue.
•
AATB-accredited organizations are recognized as tissue bank leaders.
Placenta Donation: Hospital Process
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
•
Term C-section women who satisfy standardized donor screening criteria are
eligible to donate.
•
Birth Tissue Recovery personnel provide information and perform the informed
consent and initial screening interview and documentation.
•
Placentas, not directed by the physician to Pathology, are labeled and stored in
the BTR refrigerator by the OR tech.
•
BTR personnel review and copy patient records then retrieve the tissue and
preserve it for shipment.
•
Blood is obtained for BTR infectious disease testing during the routine postoperative day-1 lab draw by hospital phlebotomy. If not, then arrangements are
made to obtain it at another time.
Placenta Donation: Hospital Process
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
O.R. Staff – C-Section Placenta Donation Procedure
DO . . .
Place lid on the basin containing the placenta.
Label lid and basin with patient ID label.
Put basin in red bag – Label the bag.
Put the basin into the “Placenta Donor Refrigerator.”
Complete the refrigerator log sheet.
DON’T . . .
Do not put any tissue into refrigerator without its identification labels.
Don’t forget to complete the log sheet.
THANK YOU !!
Any questions, ANYTIME (24hr): (336) 705-0250
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
Background: Fresh or processed amnion obtained from human placentas has been used to treat
wounds since 1910. Burns and skin ulcers were treated during the 1950s and 1960s with amnion
designed as a skin substitute. Donated placentas are used to create effective treatments for ophthalmic,
diabetic, burn, anti-adhesion, orthopedic, nerve, and tendon wounds or repair.
Placenta Donation: Informed Consent
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com
Birth Tissue Donation Informed Consent Record
Donor ID:
Purpose
•
Tissue is donated. No donor
compensation.
•
Permission for blood draw and testing.
•
Access to and retention of medical
records.
You have been asked to donate your postnatal tissue (which may include placenta, amniotic membrane, chorion, and umbilical cord) after your
elective caesarian section delivery to be used for transplantation, therapy or research. Published medical literature has shown that such tissue
can be used to treat patients with various medical conditions or who are undergoing surgery. The donation process does not involve an invasive
procedure, other than blood sample collection, and the alternative is not to donate the postnatal tissue. This donation is voluntary. Your
medical treatment will not be conditioned upon or impacted by your decision to donate, or not to donate, your postnatal tissue.
I verify, upon signature below, that the following disclosures have been explained to me:
·
I will be required to allow the collection of blood samples for infectious disease testing, including, but not limited to, testing for HIV, HTLV,
Hepatitis and Syphilis. Confirmed positive results will be reported if required by applicable law or regulation.
·
I understand that this donation is a gift, and I will not be paid for this donation. The costs directly related to the recovery of this donation
will not be charged to my family or me.
·
My signature on this Informed Consent will serve as an authorization for my physician and my hospital to release to the recovery agency,
entities to which the recovery agent supplies the donated tissue and their respective agents my medical information, including all of my
medical records and test results, for the purpose of determining medical suitability of this donation. I understand that information released
pursuant to this authorization may no longer be protected by federal privacy regulations. I may revoke this authorization at any time by
sending a written notification of my desire to revoke it to my physician. Any action already taken in reliance on this authorization cannot be
reversed, and my revocation will not affect those actions. This authorization will expire one year after the donation occurs.
·
·
·
Non‐profit and for‐profit organizations may be involved in facilitating the recovery and usage of this gift.
I understand that the donated tissue may be used for transplantation, therapy or research purposes.
I understand that my name, address, as well as required records, will be kept on file by the recovery agency.
I have read this written informed consent, or it has been read to me, I understand its content, and a copy of this consent has been provided
to me. I have also been given the opportunity to ask questions and have had my questions answered. I hereby consent to the following
donation: Postnatal Tissue (including placenta, amniotic membrane, chorion and umbilical cord)
•
•
•
Involvement of non-profit and for-profit
entities.
Signatures: Donor, Witness, and Recovery
Personnel.
Pre- or Post-operative Consent.
Donor Information
Signature of Donor
Printed Name of Donor
Date/Time
Donor’s Street Address
City/State/Zip
Phone
Signature of Recovery Personnel
Printed Name of Recovery Personnel
Date/Time
Organization of Recovery Personnel: Birth Tissue Recovery LLC, 751‐D Bethesda Road, Winston‐Salem, NC 27103 (336) 705‐0250
Signature of Witness
Printed Name of Witness
Date/Time
Witness’ Street Address
City/State/Zip
Phone
□ This written informed consent has been read to me in my native language of: _____ _______________ by an official translator.
Signature of Translator
Printed Name of Translator
SOP #:
R-F-001
Revision #:
1
Implementation Date:
August 6, 2012
1 of 1
Last Reviewed/Update Date:
September 16, 2012
This document may not be reproduced or used in any manner whatsoever without the express written permission of BTR.
CONSENT FORM: BIRTH TISSUE DONATION & MEDICAL RECORD REVIEW
Page #:
Phone
Placenta Donation: Allografts
•
Ocular surface disease.
•
Burns.
•
Diabetic ulcers.
•
Periodontal repair.
Birth Tissue Recovery LLC
Winston-Salem, NC 27103
www.birthtissuerecovery.com