CONSENTDOCUMENT:
StemCellTherapyInOsteoarthritis
Pleasereadthefollowinginformationcarefullyandmakenoteofanyquestionsyou
mighthave.
Backgroundinformation:
Platelet‐richplasmaisafractionofyourbloodwhichcontainsahighconcentration
ofplatelets.Theseareknowntocontainlargequantitiesofgrowthfactorswhich
attractstemcellsandstimulatethehealingofdamagedtissues.Stemcellsarein
peopleofallages.Theyaretheprimitiverepaircellsofthebody,andhavethe
abilitytoregeneratemanytissuesdependingonthegrowthfactorstowhichthey
areexposedandthelocationtheyareplaced.Stemcellscaneasilybeharvested
fromfatandfrombonemarrow.Asampleofeachofthesecanbetakenand
preparedforinjectionintoanarthriticjointtoassistinregeneratinghealthytissue.
Whenstemcellsareharvestedfromyourownbodyandpreparedforre‐injection,
theyarecalled“autologous”stemcells,andthereisnoriskofrejectionandno
increasedriskofcancer.
Clinicalworkoverthelastseveralyearshasestablishedthesafetyandusefulnessof
platelet‐richplasma(PRP)fortissuerepairandhealinginjointswithmildto
moderateosteoarthritis,resultinginreducedpainandimprovedfunctionformany
whohavehadthisprocedure.ThecombineduseofPRPwithfatgraftandbone
marrowhasproventobesuperiortoPRPalone,especiallyformoreadvanced
arthritis.
Procedures:
Platelet‐RichPlasmawillbeproducedbydrawing60mL(twoounces)ofyourown
bloodandplacingitinamachinecalledacentrifuge.Thismachinespinstheblood
ataveryhighspeedcausingplatelets,growthfactors,andwhitebloodcellstobe
separatedfromtherestofthebloodproducts.Itisthisconcentrationofplatelets
andgrowthfactorswhicharetheninjectedintoanarthriticjoint.Onceintroduced
intotheinjuredsite,theplateletsthenreleasemoregrowthfactorsandsignaling
proteinsattractingmorestemcellstothearea,anddirectthetissuerepairand
healingprocess.Becausethisisagradualrepairprocess,ittakesweekstomonths
tohappen.
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Additionalstemcellswillbeharvestedfromfatandbonemarrow.Toobtainafat
sample,10‐20mLoflocalanestheticisinjectedintothehip/buttockregionanda
sampleofapproximately10mLoffatisthenaspirated.Toobtainabonemarrow
sample,localanestheticisinjectedoverthepelvicbone(posterioriliaccrest)inthe
lowerbackregionandasampleofapproximately20‐30mLofbonemarrowis
aspirated.Itisthencentrifugedtogetabonemarrowconcentrate.Bothofthese
additionalproceduresinvolveverylittlediscomfortduetotheanesthetic.Thefinal
productswillthenbeinjectedinsequenceintothearthriticjoint.
Approximately4‐6weeksafteryourinitialinjection,youwillreturnforafollow‐up
visit.WewilldecidewhetheraPRPinjectiontothesamejointisrequired,followed
byafollow‐upvisit4‐6weekslater.Athirdinjectionmaybeneeded.These
plateletinjectionsallowthestemcellstocontinuegrowingandmultiplyinginto
cartilagetissue.Plateletscontinuetoremainactivefor4‐6weeks.Therepairofthe
areausuallytakes6‐9monthsbutimprovementisoftenapparentwithin2‐3
months.
Ifyouaretakinganyanti‐inflammatorymedicinesuchasMotrin/Advil(ibuprofen),
Aleve(naproxen),Celebrex(celecoxib),orVoltaren(diclofenac)pleasediscontinue
2dayspriortotreatmentandfor2daysafter.Ifyouaretaking81mgASAyoumay
continuewiththis.IfyouareonWarfarin(Coumadin)orotherbloodthinners,be
suretodiscussthiswithDr.Pagdinbeforebookingyourprocedure.Youmaytake
yourotherprescriptionmedicineasyounormallywould.Makesuretodrinkplenty
ofwater(8‐10glasses)inthe24hourspriortoyourtreatment.Nofastingis
required.
Aftertreatment,youwillbenumbintheareasoftheproceduresforapproximately
twohoursafterthetreatment.Duetonumbness,pleaserefrainfromanystrenuous
activity.Oncetheanaesthesiawearsoff,youmayresumeactivitiesastolerated.
Physicalactivitywillinnowayhinderthetreatmentandmayactuallybenefitthe
recoveryphase.Thearthriticjointthatwasinjectedwilllikelyexperiencesomepain
andsorenessfor2‐7days,andachingcanpersistforupto14days.Narcoticpain
medicinewillusuallybeprescribed,andTylenolaswellasicepackswillbehelpful.
Applyicefor20minutesevery2hourstorelievepainandswelling.Youmaynot
resumeanti‐inflammatorymedicineuntil2daysaftertreatment.Keepthesteri‐
stripsandbandagesdryfor24hours,afterwhichtimealightshowerisacceptable.
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Allowthesteri‐stripstopeeloffontheirown.Noswimmingorsoakingfor4days.
Aftersomeinitialimprovementatyourtreatmentsite,thejointmaystarttohurt
again.Fluctuatingsymptomsarenormalduringthehealingprocess.
Whatarethepossiblesideeffects?
Therisksoftheseproceduresincludebutarenotlimitedtopain(likely,over50%),
faintingorlightheadedness(lesscommon,5‐10%),bleedingandbruising(rare,less
than1%),infection(veryrare,lessthan1/50,000),allergicreactiontolidocaine
(extremelyrare),andpossiblelossoflifeorlimb(exceedinglyrare).Althoughthese
possibilitiesexist,thechanceofthemhappeningisgenerallylessthanwitha
standardsurgicaloperation.Itisalsopossiblethattheprocedureyouundergofails
toprovideyouanyimprovement.Wecannotpredictspecificbenefitsfromhaving
theseprocedures.
Foranyquestions,problems,orconcernsregardingyourparticipation,please
callDr.Pagdin’sclinicat250‐717‐3200,[email protected].
IncaseofanemergencypleasecallDr.Pagdinat250‐808‐0516orgotothe
nearesthospitalemergencydepartment.
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Consent
StemCellTherapyinOsteoarthritis
Iherebyconsenttoparticipateinthisstemcelltherapy.IconfirmthatIhaveread
theinformationcontainedinthisconsentdocumentandhavehadample
opportunitytoaskquestions,andIhavereceivedsatisfactoryanswers.Iunderstand
thatbloodwillbedrawnfrommyarm,andthencentrifugedtoobtaintheplatelet‐
richplasma(PRP)fraction,whichwillthenbeinjectedintothearthriticjointtohelp
withtissueregeneration.Inaddition,Iwillhaveasampleoffatand/orbone
marrowextractedwhichwillalsobeinjectedintothesamearthriticjoint.Thestem
cellsusedaremyowncells.
Ihavebeengivennoguaranteesastothesuccessofthistherapy.Irecognizethatas
withanyprocedure,thereareinherentriskswithperformingtheprocedures.
Theserisksincludebutarenotlimitedtoinfection,bleedingandbruising,
procedurefailure,allergicreaction,fainting,andpossiblelossoflifeorlimb.
IalsoacknowledgethatIamawarethereareothersurgicalandnon‐surgical
optionsformytreatment,butIhavechosentohavestemcelltherapy.
IunderstandthatmyparticipationisvoluntaryandthatIamfreetowithdrawat
anytimeandwithoutgivinganyreason.
________________________________________________________________________
ParticipantName(PRINT)Date
Signature
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__________________________
_______________________________________________
ProviderName(PRINT)Date
Signature
OPTIONAL:Iwouldlikemyprimarycare/specialistphysician(s)tobenotifiedofmy
participation
Y N
Nameofphysician(s)______________________________
______________________________
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