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Ethical Clearance of Stem Cell Research and Ethical Aspects of Its Service in Indonesia

Ethical Clearance of Stem Cell Research and Ethical Aspects of Its Service in Indonesia. BUDI SAMPURNA FACULTY OF MEDICINE UNIVERSITAS INDONESIA DR CIPTO MANGUNKUSUMO HOSPITAL. Introduction.

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Ethical Clearance of Stem Cell Research and Ethical Aspects of Its Service in Indonesia

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  1. Ethical Clearance of Stem Cell Research and Ethical Aspects of Its Service in Indonesia BUDI SAMPURNA FACULTY OF MEDICINE UNIVERSITAS INDONESIA DR CIPTO MANGUNKUSUMO HOSPITAL

  2. Introduction • Clinical 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 issues • In 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-ESC • human 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 Parkinson Volarevic et al. Int. J. Med. Sci. 2018, Vol. 15

  4. Ethical Challenges of i-PSC • Research 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 embryo • Risk 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 cells Volarevic et al. Int. J. Med. Sci. 2018, Vol. 15

  5. Ethical Challenges of MSC • Mesenchymal Stem Cell (MSC) can differentiate into a variety of cell types of mesodermal origin and neuro-ectodermal (neurons, astrocytes, and oligodendrocytes) or endodermal (hepatocytes) origin • MSC may promote tumor growth and metastasis, vision loss, detached retina Volarevic et al. Int. J. Med. Sci. 2018, Vol. 15

  6. Regulation in Indonesia • The 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 approved • Stem Cell for reproduction of human being is forbidden

  7. Regulation in Indonesia Minister of Health Decree No 32 of 2018: • Stem Cell based Therapy shall use stem cell • derived from human • Donated voluntarily • Non embryonic • May mesenchymal, hematopoetic, or progenitor • Autologus and Allogenic • And Secretome

  8. Standardized Stem Cell based Therapy • Should be evidence based and has established Standards of Care • Also considered as standardized Therapy on: • Autologus • No choice / no alternatives Minister of Health Decree No 32 of 2018

  9. Stem Cell Research based Therapy: • Safety approved • Translational and therapeutic application to the patients as research subjects • Aim: further evaluation of safety and efficacy • Only in hospitals appointed by MOH, Minister of Health Decree No 32 of 2018

  10. Stem Cell Research based Therapy: Requirements: • Research proposal • Ethical clearance • Permitted by the Director of the hospital • Recommendation from Stem cell Committee • Informed consent Minister 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 executive Minister 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 B • Highest accreditation • Competence Human Resources (relevant experts) needed • Relevant and sufficient Facility and equipment • Other requirement set by Committee

  13. Ethical Clearance and Committee approval • Ethical 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 confidentiality • Informed consent process • Community considerations

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