Highlights on the application of stem cell therapy as the future medicine Prof. Dr. dr. Yuyus Kusnadi, PhD, MSc PIT VII IDI Kota Bogor 1-2 November 2014

1. Highlights on the application of stem cell therapy as the future medicine
Yuyus Kusnadi
Stem cell and Cancer Institute
ReGeniC Laboratory
Pekan Ilmiah Tahunan VII
IDI Kota Bogor

2. Outline
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•Sources of stem cells
•Critical point to prepare stem cells
•Paracrine factors
•Regulation in Indonesia
•Issues in clinical study

3. Sources of stem cells?
Pekan Ilmiah Tahunan VII
IDI Kota Bogor

4. Sources of stem cells
Bone marrow
Peripheral blood
Umbilical cord blood
Adipose tissue
Wharton’s jelly
Placenta
Muscle
Amniotic fluid
Menstrual blood
Dental pulp
Etc.
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5. Transplantation
Pekan Ilmiah Tahunan VII IDI kota Bogor•Autologous•AllogeneicDonor & Recipient

6. J. Cell. Physiol. 213: 341–347, 2007
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7. Stem cell from adpose tissue
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8. Neurogenesis
Chondrogenesis
Osteogenesis
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9. Embryonic stem cells
Embryonic Stem Cells are taken from the Inner Cell Mass at the Blastocyst stage and cultured in a petri disc
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10. Pekan Ilmiah Tahunan VII IDI kota Bogor

11. •The stem cells were derived from embryos produced in IVF clinics for reproductive purpose.
NIH guidelines for ESC
•The stem cells were in excess of clinical need, meaning that donors had achieved a successful pregnancy.
•The stem cells were derived from embryos that were frozen.
•Informed consent and institutional review board approval was obtained.
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•No exchange of money was made, in order to avoid a financial influence.

12. Pekan Ilmiah Tahunan VII IDI kota Bogor

13. Induced pluripotent stem cells
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14. •Mononuclear cell
Type of stem cell will be used
•Hematopoietic stem cell
•Mesenchymal stem cell
•Differentiated stem cell
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15. Critical points to prepare stem cell
Pekan Ilmiah Tahunan VII
IDI Kota Bogor

16. Facilities
•Class D
•Class C (preparation)
•Class B (processing)
Permenkes 50 , 2012
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17. Materials & reagent
Active material
In process control
Final product
Quality Control Process
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18. Quality control product
•Sterility test
•Mycoplasma testing
•Endotoxin testing
•Characterization
•Karyotyping
•Differentiation capacity
•HLA
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19. Paracrine Factors
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IDI Kota Bogor

20. Is this cell therapy?
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21. Paracrine factors
Cytokine & Growth Factor Reviews 20 (2009) 419–427
MSCs are promising therapeutic tools
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22. Paracrine Factors
Abstract Recent studies suggest that the therapeutic effects of stem cell
transplantation following myocardial infarction (MI) are mediated by paracrine factors.
One of the main goals in the treatment of ischemic heart disease is to stimulate
vascular repair mechanisms. Here, we sought to explore the therapeutic angiogenic
potential of mesenchymal stem cell (MSC)
secretions. Human MSC secretions were collected as conditioned medium (MSC-CM)
using a clinically compliant protocol.
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23. Regulation in Indonesia
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IDI Kota Bogor

24. Are stem cells regulated?
•Autologous:Ministry of health
Permenkes 833, 2009 & Permenkes 50, 2012
•Allogeneic: National Agency for drug and food (Badan POM)
as biological product
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25. Where stem cell can be prepared?
•inthe hospital
•outsidethe hospital
Permenkes 833/834, 2009
Permenkes 50, 2012
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26. Hospital for stem cell therapy
•Only teaching hospitals (B class) are allowed to conduct clinical trial of stem cell
Permenkes 833/834, 2009
•M. Jamil
•Cipto Mangunkusumo
•Harapan Kita
•Dharmais
•Persahabatan
•Fatmawati
•Hasan Sadikin
•Karyadi
•Sardjito
•Soetomo
•Sanglah
•Permenkes 32, 2014, there are 11 hospital in Indonesia are allowed:
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27. Issues in clinical study
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IDI Kota Bogor

28. Why stem cells are so fascinating?
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29. Financial
•Collaboration
•Having Gran
•Consumables and reagents are expesive
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•Patient will pay

30. Competency of clinician
•Have ethical approval
•Recognized by professional associations or medical colleges
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31. Direct tissue injection
using delivery device
Current clinical trials of stem cells utilize two delivery
methodologies:
Intravenous
Delivery of stem cell to patient
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32. •Mononuclear cell
Type of stem cell will be used
•Hematopoietic stem cell
•Mesenchymal stem cell
•Differentiated stem cell
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33. Summary
Challenge stem cells as a the future medicine:
•Source of stem cell will be used
•Type of stem cells are administered
•Delivery system of stem cells to patient
•Reduce cost
•Therapeutic dose and timing
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34. Pekan Ilmiah Tahunan VII IDI kota Bogor

35. Thank you