and Ethical Aspects of Its Service in Indonesia BUDI SAMPURNA FACULTY OF MEDICINE UNIVERSITAS INDONESIA DR CIPTO MANGUNKUSUMO HOSPITAL Introduction Clinical studies showed potential of Stem Cell based therapy in the treatment of some degenerative autoimmune and genetic disorders ID: 1042358
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1. Ethical Clearance of Stem Cell Research and Ethical Aspects of Its Service in IndonesiaBUDI SAMPURNAFACULTY OF MEDICINE UNIVERSITAS INDONESIADR CIPTO MANGUNKUSUMO HOSPITAL
2. IntroductionClinical studies showed potential of Stem Cell based therapy in the treatment of some degenerative, autoimmune and genetic disorders.However, application of stem cell based therapy raises some ethical and safety issuesIn Indonesia, many unproven “treatment” and direct-to-customer marketing of different (non human) stem cell interventions were offered in many ways
3. Ethical Challenges of h-ESChuman embryonic stem cell (h-ESC) research has a major ethical dilemma, since it may be started with destruction of early human embryo. The pluripotency of h-ESC may generate many different cell types, including teratomas and Risk to get ParkinsonVolarevic et al. Int. J. Med. Sci. 2018, Vol. 15
4. Ethical Challenges of i-PSCResearch and Clinical Application of Induced Pluripotent Stem Cell (i-PSC) are considered morally better than h-ESC, since it does not require destruction of human embryoRisk of potential exploitation of created embryo, and risk of change natural reproduction including the possibility to derive gametes for same-sex reproduction, as well as in the asexual-reproduction Risk of transformation in to tumor cellsVolarevic et al. Int. J. Med. Sci. 2018, Vol. 15
5. Ethical Challenges of MSCMesenchymal Stem Cell (MSC) can differentiate into a variety of cell types of mesodermal origin and neuro-ectodermal (neurons, astrocytes, and oligodendrocytes) or endodermal (hepatocytes) originMSC may promote tumor growth and metastasis, vision loss, detached retina Volarevic et al. Int. J. Med. Sci. 2018, Vol. 15
6. Regulation in IndonesiaThe Law No 36 of 2009 regarding Health:Research and clinical application of Human Embryonic Stem Cell (h-ESC) is not allowed Cell transplantation, either from human or animal origin, may be applied only if its safety and benefits were approvedStem Cell for reproduction of human being is forbidden
7. Regulation in IndonesiaMinister of Health Decree No 32 of 2018:Stem Cell based Therapy shall use stem cell derived from humanDonated voluntarilyNon embryonicMay mesenchymal, hematopoetic, or progenitorAutologus and AllogenicAnd Secretome
8. Standardized Stem Cell based TherapyShould be evidence based and has established Standards of CareAlso considered as standardized Therapy on:AutologusNo choice / no alternativesMinister of Health Decree No 32 of 2018
9. Stem Cell Research based Therapy:Safety approvedTranslational and therapeutic application to the patients as research subjectsAim: further evaluation of safety and efficacyOnly in hospitals appointed by MOH, Minister of Health Decree No 32 of 2018
10. Stem Cell Research based Therapy:Requirements:Research proposalEthical clearancePermitted by the Director of the hospitalRecommendation from Stem cell CommitteeInformed consentMinister of Health Decree No 32 of 2018
11. Stem Cell Research based Therapy:Hospital appoints independent supervision Team, consist of internal and external experts The independent supervision Team monitor and evaluate the implementation of the research, and report to the Hospital executiveMinister of Health Decree No 32 of 2018
12. Stem Cell Research based Therapy held by hospital which meets:Teaching Hospital “Utama” or “Afiliasi”At least Class BHighest accreditationCompetence Human Resources (relevant experts) neededRelevant and sufficient Facility and equipment Other requirement set by Committee
13. Ethical Clearance and Committee approvalEthical clearance is issued by an ethical institution that has the authority to grant clinical research permission to human subjects.The Committee's approval / recommendation is conditional approval or recommendation with the obligation to report periodic research developments.Minister of Health Decree No 32 of 2018
14. Ethical basis for decision-making in research ethics committees Scientific design and conduct of the study Risks and potential benefits Selection of study population and recruitment of research participants Inducements, financial benefits, and financial costs Protection of research participants’ privacy and confidentialityInformed consent processCommunity considerations