1. 1 Changing landscape of SC Research and Therapeutics: Asia / India Abner M. Mhashilkar, Ph.D 2010 World Stem Cell Summit, Detroit, Michigan (Oct 6 2010)

2. 2 17950 cell therapy trials worldwide (clinicaltrials.gov)

3. 3 2919 Stem cell therapy trials worldwide (clinicaltrials.gov)

4. 4 107 registered stem cell therapy trials in Middle East region ISRAEL IRAN TURKEY Liver Cirr. Bone Regen CLI Vitiligo AMI Ocular Regen Solid Tumor; GBM Leukemia/Lympho BMT, GVHD, ESC, ALS Lymphoma Leukemia

5. 5 S.KOREA, CHINA, TAIWAN AND JAPAN CHINA SKOREA JAPAN 18 TAIWAN Diabetes 1,2, Liver-T/Kidney-T GVHD, Peridontal Bone Regen, CLI, SLE, Cerebral Palsy, MD,SCI Cancer, Liver, CV AMI, Cancer, Crohns, HaemMalig, CV Liver, Gastric, HaemMalig Cancer Peridontal

6. 6 Non-US Landscape

7. 7 NIRRH, RELIANCE,TMC, TIFR KEM-H, JASLOK-H, IIT,LTMGH, STEMADE, BIOEDEN NCCS, AFMC, DMHRC PATKI-H, Kolhapur LVPEI,CCMB, UH, NIN, CLRD, CDFD, DECCAN-H CHG, JNCASR, NCBS, IIS, MANIPAL-H, STEMPEUTICS, NIMHANS, CRYOSTEMCELL, SBMJH, INTERNATIONAL STEMCELL SERVICES LTD, ANSA/ARF; St. Theresa Hospital, Saguna Hospital RGCBT, SCTIMST CCR, KBIRVO, IIT,CI LIFECELL, APOLLO-H, NCRM, SANKARA NETRALAYA SGPIMS, CDRI AIIMS, NII, MEDANTA-H, INMAS RRH, APOLLO-H, NBRC, GANGARAM-H, FORTIS RGCIRC,PARAS-H, ARTEMES-H HLTITS, Cadilla Pharma GCRI CSCR at CMC, Chandigarh PGIMER Stem Cell Research sites in India

8. 8 Stem cell Clinical trials in India (clinicaltrials.gov) PGIMER, Chandigarh – Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus (SCT) (Phase II) INTERNATIONAL STEMCELL SERVICES LTD, Bengaluru – Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease (GVHD) (Phase I/II) – Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure (CRF) (Phase I/II) – Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury (ABMST-SCI) (Phase I/II) FORTIS (in collaboration with BEIKE) – A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia (CLI) (Phase I/II) JASLOK HOSPITAL, Mumbai – Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease (Phase I/II) CMC, Vellore – Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of GVHD (Phase I/II) Sri Ramachandra University Medical Center and LifeCell (with Harvest Technologies) – Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI (Phase I/II) Medanta The Medicity (with Harvest Technologies) – BMAC Enhanced Coronary Artery Bypass Grafting (CABG) using Harvest SmartPReP2 BMAC System for Congestive Heart Failure (CHF) (Phase I/II) STEMPEUTICS, Bengaluru – Mesenchymal Stem Cells in CLI (Phase I/II) – Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI (Phase I/II) AIIMS (Acute Ischemic Stroke/ CLI/ Mature teeth regen) /Manipal (Allogeneic MSC-Cardiomyopathy/ Osteoarthritis); Mangalore (COPD/Liver Cirrhosis); Reliance (SCI); RPCOS, NDelhi (BM-MSC for ARMD and RP); St. Theresa Hospital, Bangalore (Osteoarthritis); Saguna Hospital, Bangalore (CRF)

9. 9

10. 10 Indian Govt constitutes National Apex Committee (NAC) for monitoring stem cell research Almost three years after announcing the Guidelines for Stem Cell Research Regulation, the Union health ministry has finally constituted the much awaited National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). Dr Alok Srivastava of Christian Medical College (CMC), Vellore will be the chairman of the 12 member committee. ICMR will act as the secretariat for the NAC (Senior Scientists at the ICMR, Dr Vijay Kumar and Dr Geeta Jotwani will represent ICMR in the NAC). In addition, the committee will include deputy chairman, member secretary and nominees from DBT, DST, CSIR, ICMR, DCGI, DAE, and biomedical experts drawn from various disciplines like pharmacology, immunology, cell biology, haematology, genetics, developmental biology, clinical medicine and nursing. There will be a legal expert, social scientist, and a womens representative in the NAC. In addition consultants/experts could be consulted for specific topics and advice. The NAC will have two main functions: general oversight and policy monitoring function; and to review specific controversial or ethically more sensitive research proposals and will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy. All institutions involved in any type of stem cell research and therapy shall be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). The NAC will set up standards for safety and quality, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation. August 18, 2010, 0800 IST – Source : Healthcare Industry Regulations in India, Pharma Biz News

11. 11 India / Asia challenge Stem cells have raised hopes for patients – Potential to relieve symptoms /treat debilitating, life-threatening diseases. – Can potentially replace the diseased cells/tissue/organ in the body in contrast to existing practice where diseased cells are treated with drugs and antibiotics. – Beware factor!! Stem cell research in India is still in its infancy and cautions about claims by individual groups needs diligent scrutiny and transparent validation. The NAC regulated mechanism will be implemented to regulate these issues. With U.S. stem cell treatments limited, patients are taking leaps of faith in seeking stem cell treatments in places as far away as China, India, Thailand, S.Korea, Russia and Brazil. Treatments using embryonic or fetal stem cells are in the experimental stage in the United States and are not approved for commercial use by the Food and Drug Administration. But they remain in a regulatory gray area in China, neither sanctioned nor banned. The Chinese government allows 50 or so stem cell clinics to operate freely. Several Chinese health officials have expressed concern about the lack of oversight. Scholars affiliated with the government say they expect some regulations to be introduced soon. Still a Fragmented Sector, Needs Transparency and National and International Consolidation. Understanding of Optimal Niche Environment for Optimal and safe Implantation still a work in progress Several Adult Stem cells clinical studies underway to evaluate its full potential. Effective Programs / Events for Public Awareness of Stem Cell Banking and its long-term values also need addressing