Burchett/6SenatorYouS.B.

_____

ABILL
ToincreasefundingallocatedtotheNationalInstitutesofHealth(NIH)forstemcellresearchby10billiondollars.

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BeitenactedbytheSenateandHouseofRepresentativesoftheUnitedStatesofAmericainCongressassembled,

SECTION1.SHORTTITLE
ThisactmaybecitedastheStemCellActof2015.

SECTION2.FINDINGS
Congressherebyfindsanddeclaresthat,
1)
Embryonicstemcellsarepluripotent,meaningtheyhavethepotentialtoregenerateanyofthetissuesinthebody.
2)
Somebone,skinandcornealdiseasesorinjuriescanbetreatedbygraftingtissuesthatarederivedfromor
maintainedbystemcells.
3)
Every34seconds,onepersondiesofcardiovasculardiseaseintheUnitedStatesresultinginabout2,600
cardiovasculardiseaseinduceddeathsperday.
4)
Asof1:13amonOctober20,2015,122,535peopleintheUnitedStatesneedalifesavingorgantransplant,butonly
79,088ofthemareactivewaitinglistcandidates.
5)
Umbilicalcordbloodcellshavealreadybeentestedtoregeneratedamagedhearttissueinrats,mice,andpigs.
6)
MayoClinicsuccessfullyharvestedstemcellsfromatrialpatientsbonemarrowandtreatedtheminthelaboratory
tobecomecardiaccellsthenewlygeneratedcardiaccellswereinjectedintohishearttocreatehealthytissue.
7)Chemotherapyhalts/slowsallrapidcellulardivision,thusaffectinghealthycellsandcancerouscellsalike.
8)
Adultstemcellsarealreadyusedtotreathematologicalmalignanciesandtotreatthesideeffectsofcancer
chemotherapy.
9)
Thehealthy,transplantedstemcellscanrestorethebonemarrowsabilitytoproducethebloodcellsthepatient
needs,whereasradiationandchemotherapymaydestroybonemarrowandinhibitredbloodcellproduction.
10)
ResearchesfoundevidencethatParkinsonslikedamageinratsbrainswerereversedwheninjectedwithstem
cells.
11)
Nonmyeloablativeallogeneicstemcelltransplantationcanactivatealongtermregressionofmetastaticrenalcell
carcinomaincancerpatientswhoareunresponsivetochemotherapy,radiation,andothertypesofconventional
immunotherapy.
12)
AstemcelltransplantiscurrentlytheonlyknowncureforDiamondBlackfanAnemia.
13)
Scientistswereabletousehumanembryonicstemcellstoproducemassquantitiesofhumaninsulinproducingbeta
cellsthathadnearlyallthesamepropertiesofnormallyfunctioningbetacells.
14)
InatrialconductedinMarch2010,resultsshowedthatallogeneicstemcelltransplantsweremoreeffectivethan
chemotherapyinsubsidingcancerinolderleukemiapatients.
15)Inducedpluripotentstemcells(iPSCs)areadultstemcellsthathavebeenengineeredtocontainpropertiesnearly
identicaltothoseofembryonicstemcellstheyarecurrentlyusedfordrugdevelopmentanddiseasemodelingonly.

SECTION3.STATUTORYLANGUAGE
A)TheStemCellActof2015shallincreasethefederalgovernmentsfundingofallformsofstemcellresearchby
withdrawing10billiondollarsfromtheU.S.MilitarysbudgetandallocatingittotheNIH(NationalInstitutesof
Health)forstemcellresearch.Thismoneyshallbeusedtoexpandresearchofhumanembryonic,nonhuman
embryonic,nonembryonichuman,nonembryonicnonhuman,humanumbilicalcordblood/placenta,andnonhuman
umbilicalcordblood/placentastemcellresearch.TheNIHshalldistributesuchfundstonationwidestemcellinstitutes
suchastheCaliforniaInstituteofRegenerativeMedicine,JohnsHopkinsInstituteforCellEngineering,NewYorkStem
CellScienceandHarvardStemCellInstitute,withthepreconditionthatthefundsshallbededicatedtostemcell
researchprojectsonly.
B)TheAgencyforHealthcareResearchandQualityshallberesponsibleforensuringthatthefundsareusedonlyto
furtherstemcellresearchfordiseaseswithnocurrentlongtermcure.
C)TheStemCellActof2015shallbeenactedonJanuary1,2016,andshallbereevaluatedonJanuary1,2021.

Thecell,thoughsmall,shouldnotbeunderestimated.AfewgeneticmutationsincellularDNAcangiverisetoa
numberofdegenerativediseasesmanyofwhichcurrentlyhavenocure.SuchdiseasesincludeAlzheimersDisease,diabetes,
cardiovasculardisease,cancerandthelikediseasestooaggressivetobecounteractedwithasimplepillorvaccination.Thus,
thebestoptionistofightthesediseasesusingtheminusculestructuresfromwhichtheystartcells.Stemcellshavebecome
vitalintreatingsomedegenerativediseases,andholdpromisefortreatingcountlessmoreinthefuture.Stemcellresearch
fundingshouldbeincreasedbecauseconventionalformsofimmunotherapyaresaferandmoreeffectivewhendonein
conjunctionwithstemcelltherapy,stemcellsareabundantandreadilyavailablefortransplants,andstemcellsarealready
successfulintreatingsomedegenerativediseases.
Unlikechemotherapy,stemcelltransplantsarecapableoftreatingcancerwithoutdeterioratingthebodysexisting
healthytissue.Chemotherapysgoalistoterminateallrapidcelldivision.Unfortunately,itcannotdistinguishcancercellsfrom
healthybodycellsthereasonitalsodamagescellsintheblood,mouth,nose,nails,intestinaltract,hairandotherregionsof
thebody.Topreventthis,chemotherapyandstemcelltherapyshouldalwaysbedoneinconjunction.Thechemotherapywill
haltcancerouscelldivision,andthenthestemcellinjectionwillcatalyzeproductionofhealthytissue.Theunspecializedstem
cellscellscanspecializetoreplacethedeadmalignantcellsaswellastheotherbodycellsthatwerekilled.Thismethodof
treatmentridsthebodyofcancerwithoutadverseeffects.
Withstemcells,patientsawaitingorgantransplantsmaynolongerhavetosufferformonthsbeforefinallygettinga
viableorgan.Conventionally,degenerativediseasepatientsexperiencingorganfailureareputonadonorlist.Thisleadstoa
significantproblem:toomanypatientsinneedoftransplants,butnotenoughviableorgans.Asof10:57amofNovember10,
2015,122,293peopleintheUnitedStatesneedalifesavingorgantransplant,butonly78,863ofthemareactivewaitinglist
candidatesapproximatelytwentytwopatientlivesarelostperday.Thesteadilyincreasinggapbetweenorgansupplyand
demandmustgetsmallertogivedegenerativediseasepatientsasecondchanceatlife.Stemcells,asopposedtowholeorgans,
aremuchmoreavailablefortransplantation.Becausetheyareunspecializedcells,stemcellshavetheabilitytogeneratetissues
forallorgans.Withthiscapability,stemcellscanbeusedtoregularlyreplacedamagedorgancellsthuseliminatingtheneed
forfullorgantransplantation.Thiscaneithersustainthefunctionalityoftheoriginalorganuntiladonororganbecomes
available,orfullyhealtheoriginalorganaltogether.
Thoughstemcellresearchisstillverymuchinprogress,ithasalreadyfoundeffectivetreatmentsforsome
degenerativediseases.Currently,stemcelltransplantsarethemostimpactfultreatmentforbonemarrowrelateddiseases.A
stemcelltransplantcanhelprestorethemarrowsabilitytomakeredbloodcells,anditiscurrentlytheonlyknowncurefor
DiamondBlackfanAnemiaadiseasethatinhibitsbonemarrowsproductionofredbloodcells.Whileconductinga
laboratorytestondiabeticrats,scientistswereabletousehumanembryonicstemcellstoproducemassquantitiesofhuman
insulinproducingbetacellsthathadnearlyallthesamepropertiesofnormallyfunctioningbetacells.Thisbreakthrough
providesmedicinewithadiabetictreatmentthatcanreplacethelongusedinsulininjection.Afterenoughtreatmentsessions,
thepatientmayhaveenoughbetacellstoensurealifeofregulatedinsulinlevels.AtMayoClinic,asuccessfulclinicaltrial
usingstemcellstorepairpostheartattackcardiacscartissuedrasticallyimprovedclinicaltrialparticipantMiroslavDlacics
life.MayoClinicperformedanautologoustransplantonhim,meaningthattheclinicharvestedstemcellsfromhisownbone
marrow.Subsequently,thebonemarrowcellsweretreatedinthelaboratorytobecomecardiaccellsthenewlygenerated
cardiaccellswereinjectedintohishearttocreatehealthytissue.Thistrialsgroundbreakingresultsarethefirstofitskindthey
provethatstemcellshavetheabilitytotakedownthenationsnumberonekiller.
Notsurprisingly,useofstemcellsinmedicinehascatalyzedanuproar.Mostofitsopponentsarguethatspecifically
embryonicstemcellresearchisunethicalbecauseharvestingthecellkillstheblastocyst,thepreembryonicstructurethat
givesrisetoembryonicdevelopment.However,mostembryosareharvestedfromeggsfertilizedinvitro(outsideofthehuman
body)frominvitrofertilizationclinics.Theseeggsarecollectedinabundancebeforetheyareeachfertilizedandfrozen.Once
theembryoistransferredandthefemaleissuccessfullyimpregnated,theexcesseggsareofteneitherdisposedoforsentto
stemcellresearchfacilitiesifthedonorsgiveconsent.Itisnotunethicaltoexperimentwithembryosthatwouldotherwisebe
thrownaway.Prohibitingembryonicstemcellresearchwouldineffecttakeawayopportunitiestodiscovercuresformost
degenerativediseasesbecauseembryonicstemcellsarepluripotent.Theyhavetheabilitytodifferentiateintoallcelltypes,
whereasadultstemcellsareonlyabletodifferentiateintocelltypeoftheirtissueorigin.Anotherargumentofopponentsclaims
thatstemcelltherapyisdangerous.SuchargumentsincludeconcernsaboutGVHD(GraftVersusHostDisease),acondition
thatresultswhenthedoneeswhitebloodcellsattackhisorherownbodycellsinresponsetoatransplant.Transplantrejection,
thoughdangerousinsomeinstances,canactuallybebeneficialforacancerpatientasthewhitebloodcellsattackthebody
cells,italsoattacksthecancercells.PatientswhoexperienceGVHDtendtohaveslimmerchancesofrelapsing.Withoutthe
stemcellrevolution,medicinewouldhavenohopesofcounteractingdegenerativedisease,whichspecificallyneedstotarget
cellstodisappear.
Thestemcellsavailability,abilitytoenhanceconventionalimmunotherapyresults,andclinicaltrialsuccessrate
makesitmedicinesmostfeasibletreatmentfordegenerativediseases.SuchdiseasesarisefrommutationsincellularDNA,but
spreadthroughoutthebodywithinashorttimeframe.Theyaretooaggressiveandsmarttobetamedbytheconventionalforms
oftherapythatcurrentlyexist:chemotherapy,radiation,insulininjections,andsoforth.Tobetamed,theseconventionalforms
ofimmunotherapymustbeadministeredincombinationwithstemcelltherapy.Withoutadvancementinstemcellresearch,
degenerativediseaseswillcontinuetobetheleadingcauseofdeathintheUnitedStates.Increasingfundingforstemcell
researchwillencouragemoreclinicaltrialsthatwillfurthermedicinesunderstandingandusageofstemcells,andbeforelong,
therewillbefarlessdiseaseswithoutcureinthisworld.