About Us
Stempeutics Research Private Limited (Stempeutics) is a leading stem cell company developing stem cell based medicinal products, with facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia). The company is in the process of bringing the first stem cell therapy product to the Indian market.
Stempeutics has completed pre clinical studies demonstrating the appropriate safety profile of human bone marrow-derived ex vivo cultured adult mesenchymal stem cells in allogenic settings.
Stempeutics obtained Drug Controller General of India (DCGI) / Indian Council of Medical Research (ICMR) approval for conducting multi centric phase I/II combined double blind randomized allogenic clinical trials (on-going) for its two most advanced programs, indicated in acute myocardial infarction (AMI) and critical limb ischemia (CLI). This is the FIRST allogenic stem cell clinical trial approved in India. A phase 3 study is planned to be conducted in India in 2011; another phase III study will be planned outside India. This second phase 3 is likely to be supportive for the registration of the product in ASEAN countries.
In addition, several programs are currently awaiting DCGI approval for various indications including chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and diabetes mellitus. In Malaysia Stempeutics is in advanced stage in getting Ministry of Health approval for Cerebral Stroke clinical trials. Stempeutics’ long-term objective is to market its products in the European and North American markets.
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