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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
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Outline
Pekan Ilmiah Tahunan VII IDI kota Bogor
• Sources of stem cells
• Critical point to prepare stem cells
• Paracrine factors
• Regulation in Indonesia
• Issues in clinical study
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Sources of stem cells?
Pekan Ilmiah Tahunan VII
IDI Kota Bogor
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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.
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Transplantation
Pekan Ilmiah Tahunan VII IDI kota Bogor
• Autologous
• Allogeneic
Donor & Recipient
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J. Cell. Physiol. 213: 341–347, 2007 Pekan Ilmiah Tahunan VII IDI kota Bogor
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Stem cell from adpose tissue
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Neurogenesis
Chondrogenesis
Osteogenesis
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Embryonic stem cells
Embryonic Stem Cells are taken from the Inner Cell
Mass at the Blastocyst stage and cultured in a petri
disc
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Pekan Ilmiah Tahunan VII IDI kota Bogor
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• 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.
Pekan Ilmiah Tahunan VII IDI kota Bogor
• No exchange of money was made, in order to avoid a
financial influence.
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Pekan Ilmiah Tahunan VII IDI kota Bogor
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Induced pluripotent stem cells
Pekan Ilmiah Tahunan VII IDI kota Bogor
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• Mononuclear cell
Type of stem cell will be used
• Hematopoietic stem cell
• Mesenchymal stem cell
• Differentiated stem cell
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Critical points to prepare stem cell
Pekan Ilmiah Tahunan VII
IDI Kota Bogor
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Facilities
• Class D
• Class C (preparation)
• Class B (processing)Permenkes 50 , 2012
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Materials & reagent
Active material
In process control
Final product
Quality Control Process
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Quality control product
• Sterility test
• Mycoplasma testing
• Endotoxin testing
• Characterization
• Karyotyping
• Differentiation capacity
• HLA
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Paracrine Factors
Pekan Ilmiah Tahunan VII
IDI Kota Bogor
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Is this cell therapy?
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Paracrine factors
Cytokine & Growth Factor Reviews 20 (2009) 419–427
MSCs are promising therapeutic tools
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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.Pekan Ilmiah Tahunan VII IDI kota Bogor
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Regulation in Indonesia
Pekan Ilmiah Tahunan VII
IDI Kota Bogor
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Are stem cells regulated?
• Autologous: Ministry of healthPermenkes 833, 2009 & Permenkes 50, 2012
• Allogeneic: National Agency for drug and food
(Badan POM)
as biological product
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Where stem cell can be prepared?
• in the hospital
• outside the hospitalPermenkes 833/834, 2009
Permenkes 50, 2012
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Hospital for stem cell therapy
• Only teaching hospitals (B class)
are allowed to conduct clinical trial of
stem cellPermenkes 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:
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Issues in clinical study
Pekan Ilmiah Tahunan VII
IDI Kota Bogor
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Why stem cells are so fascinating?
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Financial
• Collaboration
• Having Gran
• Consumables and
reagents are expesive
Pekan Ilmiah Tahunan VII IDI kota Bogor
• Patient will pay
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Competency of clinician
• Have ethical approval
• Recognized by
professional associations
or medical colleges
Pekan Ilmiah Tahunan VII IDI kota Bogor
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Direct tissue injection
using delivery device
Current clinical trials of stem cells utilize two delivery
methodologies:
Intravenous
Delivery of stem cell to patient
Pekan Ilmiah Tahunan VII IDI kota Bogor
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• Mononuclear cell
Type of stem cell will be used
• Hematopoietic stem cell
• Mesenchymal stem cell
• Differentiated stem cell
Pekan Ilmiah Tahunan VII IDI kota Bogor
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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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Thank you