ELSI of Regenerative Medicine · 2008-04-18 · 04- -1111-0505 ELSI regenerative medicineELSI...

ELSI of Regenerative ELSI of Regenerative MedicineMedicine

Experiences from a developing country ThailandExperiences from a developing country Thailand

Somsak ChunharasSomsak ChunharasSecretary generalSecretary generalNational Health FoundationNational Health Foundation

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Four types of Stem cellsFour types of Stem cells

Adult stem cells Adult stem cells –– embedded in each organembedded in each organHaematopoeticHaematopoetic stem cells stem cells –– bone marrow and bone marrow and peripheral bloodsperipheral bloodsCord blood stem cells Cord blood stem cells –– umbilical cordsumbilical cordsEmbryonic stem cells Embryonic stem cells –– fertilized embryo, fertilized embryo, SCNT, ESSCNT, ES--like like


Technology use for regenerative Technology use for regenerative medicinemedicine

Regenerating damaged cells and organsRegenerating damaged cells and organsDM, DM, AlzeimerAlzeimer, IHD, cord injury, etc, IHD, cord injury, etc

HematopoieticHematopoietic stem cells and treatment of stem cells and treatment of diseases in Thailanddiseases in Thailand

CancersCancersChildhood cancer (leukemia)Childhood cancer (leukemia)Various types of cancersVarious types of cancers

Genetic diseasesGenetic diseasesThalassemiaThalassemia (stem cell transplant) (stem cell transplant)


Three Areas of Concern Three Areas of Concern

Regulatory requirement in the use of new Regulatory requirement in the use of new technologies for regenerative medicinetechnologies for regenerative medicineELSI in research in regenerative ELSI in research in regenerative medicinemedicineStem cell bankStem cell bank-- public or private goods?public or private goods?


Questions in using stem cellsQuestions in using stem cells

Do we need to Do we need to ““regulateregulate”” ““processed/storedprocessed/stored”” autologousautologous stem stem cells (cord/cells (cord/haematopoietichaematopoietic))How do we control the use of How do we control the use of ““ heterologousheterologous stem cellsstem cells””??

The same as blood and blood productsThe same as blood and blood productsThe same requirement as The same requirement as ““drugsdrugs””The same as The same as ““organsorgans””

Needs for research/trials before approval for use? Or is it justNeeds for research/trials before approval for use? Or is it justanother types of blood products?another types of blood products?Needs for registration? Needs for registration? –– prepre--packaged stem cells of different packaged stem cells of different kindskindsNeeds for ADR/QA?Needs for ADR/QA?


ปญหาทางจริยธรรม

โครงการจีโนมและหลังจโีนม

ปญหาทางจริยธรรมปญหาทางจริยธรรม

โครงการโครงการจีโนมจีโนมและหลังจีและหลังจีโนมโนม

การทําลายชีวิตการทําลายชีวิต

ทรัพยสินทางปญญาทรัพยสินทางปญญา

สิทธิความเปนสวนตัวสิทธิความเปนสวนตัว

ความเปนเจาของ “ชิ้นสวน”ความเปนเจาของ “ชิ้นสวน”

ศักดิ์ศรีของความเปนมนุษยศักดิ์ศรีของความเปนมนุษย


Stem cells Research: nonStem cells Research: non--ESES

No restriction towards research using nonNo restriction towards research using non--ES ES Legal framework for ownership and IP sharing Legal framework for ownership and IP sharing not yet clearnot yet clear –– mooremoore cell linecell lineRules re obtaining cord blood cells for Rules re obtaining cord blood cells for research not yet established research not yet established ––

informed or written consents from parents?informed or written consents from parents?Commercialization of cord blood stem cells?Commercialization of cord blood stem cells?


Difficult Questions that Need to be Difficult Questions that Need to be AddressedAddressed re ESre ES

Can we do research on embryo at the Can we do research on embryo at the expenses of a potential human life?expenses of a potential human life?Is it ethical to trade a (potential) human Is it ethical to trade a (potential) human life with a potential treatment?life with a potential treatment?Is it ethical to fertilize embryo Is it ethical to fertilize embryo purposefully for stem cell harvesting?purposefully for stem cell harvesting?


Is it ethical to use already fertilized ovum Is it ethical to use already fertilized ovum (through IVF) for stem cells? Who has the (through IVF) for stem cells? Who has the right to those embryos? right to those embryos? Is it ethical to do somatic cell nuclear transfer Is it ethical to do somatic cell nuclear transfer to produce stem cell? Is it possible to prevent to produce stem cell? Is it possible to prevent them from being used for cloning new human them from being used for cloning new human beings?beings?Is it ethical to sell eggs and sperms?Is it ethical to sell eggs and sperms?

Difficult Questions that Need to Difficult Questions that Need to be Addressed re ESbe Addressed re ES


Stem cell research : ESStem cell research : ES

ES research = killing?ES research = killing?If allowed =>If allowed =>

imported ES for research imported ES for research –– allowed or not?allowed or not?Use of ES from frozen embryo (allowed subject to Use of ES from frozen embryo (allowed subject to consent from parents?)consent from parents?)Purposefully fertilizing embryo to obtain ES for Purposefully fertilizing embryo to obtain ES for research not encouraged (not barred?)research not encouraged (not barred?)SCNTSCNT--derived ES for research derived ES for research

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Stem cells (cord blood) banking

Commercial companiesNeeds to be regulated? – not allowed?What framework? – blood bank (safety), organ bank (safety and sources), private hospitals?

Thai Red crossShould it be barred from operating cord blood bank for individual use? – keeping cord blood takes longer time frame compared to autologous blood storage


Stem cell (cord blood banking)

How to obtain “cord blood” – need for informed and written consent?Donated cord blood could not be charged when used even when kept by private companies?No commercial possibilities of “cord blood”(quasi property)Rules for storage – pro-public or pro-private

Compulsory donation after X years of non-payment ?

ELSI regenerative medicineELSI regenerative medicine 13130404--1111--0505

Examples of Regulations & Rules


Examples of Examples of ““stem cellsstem cells”” regulation regulation for usefor use

Marrow cells Marrow cells No regulation for No regulation for autologousautologous useuseThai medical council sanctioning institutes suitable Thai medical council sanctioning institutes suitable for providing such servicesfor providing such services

Endothelial progenitor cells (EPC)Endothelial progenitor cells (EPC)Needs to meet safety standard, applying same rules Needs to meet safety standard, applying same rules as medical equipmentas medical equipmentNo clear rulings on needs for No clear rulings on needs for ““clinical researchclinical research””the way new drugs needed to go thruthe way new drugs needed to go thru


Examples of Examples of ““Stem CellsStem Cells”” regulation regulation for usefor use

No rules and regulation yet (needs for clinical No rules and regulation yet (needs for clinical trials, registration, safety screening, QA, etc) trials, registration, safety screening, QA, etc)

XenoXeno--stem cellsstem cellsEmbryonic stem cells Embryonic stem cells –– ESES--derived (either locally derived (either locally or imported)or imported)Cord blood ( tends to be treated the same as Cord blood ( tends to be treated the same as hematopoietichematopoietic cells?)cells?)


Rulings So Far

Research on embryonot allowed at allallowed only for those coming from fertilization not from somatic cell transferallowed for those below 14 days (regardless of sources) – England


Use of (thawed) Embryoacceptable upon consent from both parentsno clear ruling in case of death or divorcesno commercialization is allowed/acceptedunused embryo must be destroyedunused embryo must be kept indefinitely

Rulings So Far


Commercialisation and use of eggs and sperms to produce new embryo for ES

no sale of any human tissues are allowedno explicit ruling against sale of human tissues of any kindsocially unacceptable to sale tissues for health or even research purposes ( donation only)prohibiting doctors from obtaining eggs for purposes other than IVFno explicit ruling against IVF for ES

Rulings So Far


Somatic Cell Nuclear Transferabsolutely not allowedallowed for ES harvesting only (therapeutic cloning) but not for reproductive purposesruling prohibiting medical personnel to do SCNT – what about scientists?no ruling

Rulings So Far


Intellectual Property SharingOwners of tissues are not entitled to IP benefits though cell lines were produced out of the tissues obtainedthere should be explicit statement about IP sharing in the consent form when obtaining tissues for research (whether yes or no)

Rulings So Far


Most countries belong to the group Most countries belong to the group

““No Explicit Ruling of Any KindNo Explicit Ruling of Any Kind””


What have been done to address the issues?

Consulting religious groups – no single set of values towards the beginning of lifeConsulting the legal experts – different rulings re the use of (thawed) embryo and commercialization of eggs and sperms and other human tissuesconsulting the society – inadequately informed and too diverse value to reach consensus

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