Highlights on the application of stem cell therapy as the future medicine yuyus kusnadi

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

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

Sources of stem cells?

Pekan Ilmiah Tahunan VII

IDI Kota Bogor

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

Transplantation

Pekan Ilmiah Tahunan VII IDI kota Bogor

• Autologous

• Allogeneic

Donor & Recipient

J. Cell. Physiol. 213: 341–347, 2007 Pekan Ilmiah Tahunan VII IDI kota Bogor

Stem cell from adpose tissue

Pekan Ilmiah Tahunan VII IDI kota Bogor

Neurogenesis

Chondrogenesis

Osteogenesis

Pekan Ilmiah Tahunan VII IDI kota Bogor

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

Pekan Ilmiah Tahunan VII IDI kota Bogor

• 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.

Pekan Ilmiah Tahunan VII IDI kota Bogor

Induced pluripotent stem cells

Pekan Ilmiah Tahunan VII IDI kota Bogor

• 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

Critical points to prepare stem cell

Pekan Ilmiah Tahunan VII

IDI Kota Bogor

Facilities

• Class D

• Class C (preparation)

• Class B (processing)Permenkes 50 , 2012

Pekan Ilmiah Tahunan VII IDI kota Bogor

Materials & reagent

Active material

In process control

Final product

Quality Control Process

Pekan Ilmiah Tahunan VII IDI kota Bogor

Quality control product

• Sterility test

• Mycoplasma testing

• Endotoxin testing

• Characterization

• Karyotyping

• Differentiation capacity

• HLA

Pekan Ilmiah Tahunan VII IDI kota Bogor

Paracrine Factors

Pekan Ilmiah Tahunan VII

IDI Kota Bogor

Is this cell therapy?

Pekan Ilmiah Tahunan VII IDI kota Bogor

Paracrine factors

Cytokine & Growth Factor Reviews 20 (2009) 419–427

MSCs are promising therapeutic tools

Pekan Ilmiah Tahunan VII IDI kota Bogor

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

Regulation in Indonesia

Pekan Ilmiah Tahunan VII

IDI Kota Bogor

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

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

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

Issues in clinical study

Pekan Ilmiah Tahunan VII

IDI Kota Bogor

Why stem cells are so fascinating?

Pekan Ilmiah Tahunan VII IDI kota Bogor

Financial

• Collaboration

• Having Gran

• Consumables and

reagents are expesive

Pekan Ilmiah Tahunan VII IDI kota Bogor

• Patient will pay

Competency of clinician

• Have ethical approval

• Recognized by

professional associations

or medical colleges

Pekan Ilmiah Tahunan VII IDI kota Bogor

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

• 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

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

Pekan Ilmiah Tahunan VII IDI kota Bogor

Pekan Ilmiah Tahunan VII IDI kota Bogor

Thank you