Stempeutics Research, a group company of Manipal Education & Medical Group announced today that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel allogeneic product is developed from mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has 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 share holders - 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.
Commenting on the DCGI’s approval, Mr BN Manohar, CEO, Stempeutics Research said “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”.
