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international focus.


Stempeutics Research – International member profile


Stempeutics Research is a leading stem cell research company developing stem cell based medicinal products, with GMP compliant facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia). The company is funded by Manipal Education & Medical Group and Cipla and it was incorporated in January 2006.


FDA i.e. Drug Controller General of India (DCGI) for AMI & CLI indication. The company has filed for Phase IIB/III approval for CLI. In addition, Stempeutics has received Phase II clinical trial approval from Indian FDA for COPD, LC, OA and DM indications. In Malaysia, Stempeutics has received Malaysian FDA i.e. National Pharmaceutical Control Bureau (NPCB) approval for Phase I/II CS trial and Phase II OA clinical trials. Stempeutics’ long-term objective is to market its products in the Asian, European and North American markets.


Right:


Stempeutics Lab at Bangalore, India


Bottom Right: Stempeutics Lab at Kuala Lumpur, Malaysia


Stempeutics has been doing extensive research and developmental studies to understand the biology and differentiation pattern of adult mesenchymal stem cells (MSCs) in order to make successful use of these cells for meeting unmet medical needs. Currently the company is focusing on 8 products covering Cardiovascular – Acute Myocardial Infarction (AMI), Critical Limb Ischemia (CLI) & Ischemic Cardiomyopathy (ICM), Orthopedics – Osteoarthritis (OA), Respiratory – Chronic Obstructive Pulmonary Disease (COPD), Endocrinology – Diabetes Type II (DM), Central Nervous System – Cerebral Stroke (CS) and Gastroenterology – Liver Cirrhosis (LC) diseases for which there are no effective treatments available. These 8 products are under various stages of development. Stempeutics product name is “Stempeucel” and it is based on allogeneic MSCs derived from bone marrow of healthy voluntary donors.


Stempeutics has completed pre clinical studies demonstrating the appropriate safety profile of Stempeucel product. Stempeutics has also completed initial Phase I/II human clinical trial approved by Indian


28 www.regener8.ac.uk


While the initial foray of Stempeutics is in bone marrow derived MSCs, Stempeutics is investing on its R&D programs to bring out some innovative products in the near future based on MSCs derived from Wharton’s Jelly and Adipose Tissues. The company is investing money on large scale up scaling of products so as to make the product affordable for the larger population of the society. It is also working on a point- of-care medical device project for providing autologous therapy using ADSC.


Stempeutics obtained “Bio Nexus” status in Malaysia – granted by the Malaysian Biotechnology Corporation and its facility is approved by NPCB for GMP compliance. In India the facilities are approved by Department of Scientific & Industrial Research (DSIR) and ISO 9001:2008 certified. It is also inspected by Indian Council of Medical Research (ICMR) and confirmed to meet their standard guide lines. Scientists working at Stempeutics have filed 19 patents and they have published 28 peer reviewed international publications.


For further information visit www.stempeutics.com


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