Stempeutics Research, a group company of Manipal Education & Medical Group received the Drug Controller General of India (DCGI) clearance for its Investigational Medicinal Product “Stempeucel” to conduct phase II clinical trials. The human studies are for patients suffering from osteoarthritis, diabetes mellitus – type2, liver cirrhosis and chronic obstructive pulmonary disease.
Stempeucel is an allogeneic product developed from mesenchymal stem cells derived from donated bone marrow using the company’s proprietary technology.
Earlier the company received approval from DCGI for phase I/II clinical trial for acute myocardial infarction and critical limb ischemia in March 2009. Stempeutics is funded by its shareholders - Manipal Group and Cipla.
Being the first of its kind stem cell product developed in India, it took almost 15 months to get DCGI clearance. DCGI referred Stempeutics proposal to Indian Council for Medical Research for review and recommendation. ICMR constituted an expert stem cell committee to examine the proposal and the committee accepted the study as phase II clinical trials. The DCGI’s clearance of Stempeucel product for the four debilitating diseases is one of Stempeutics’s significant accomplishments towards its goal of bringing safe, effective and affordable stem cell based product in India in the near future. India becomes one of the leading countries after USA to enter this phase of stem cell research, stated BN Manohar, CEO, Stempeutics Research.
The clinical trial will be a multi-centric, placebo controlled, double blind, study. Based on the successful outcome of clinical studies plans to introduce the first stem cell based drug - available off the shelf in India by end of 2013, he added.
“We are the only company in India which has achieved this significant mile stones. Our team is working towards hitting the first stem cell “off-the-shelf” product in the Indian market by the end of 2013. Stempeucel product has been developed using international standards with stringent quality control. We have pioneered large scale upscaling of mesenchymal stem cells and we expect that it will be the most cost effective product globally, stated the Stempeutics chief.
Stempeutics has completed pre clinical studies demonstrating the appropriate safety profile of Stempeucel product. In Malaysia, Stempeutics is in the final stage of getting Malaysian FDA which is a National Pharmaceutical Control Bureau (NPCB) approval for CS and OA clinical trials. Stempeutics’ plans are to market its products in the Asian, European and North American markets.
The company is also investing on its R&D programs to bring out some innovative products in the near future based on MSCs derived from Wharton’s Jelly, Adipose Tissues and Dental Pulp.