India’s first stem cell clinical trial against four incurable diseases would commence in two Bangalore hospitals in two months' time.
The Drug Controller General of India (DCGI) has granted clearance to Stempeucel, the medicinal product to be manufactured by Stempeutics Research, to conduct phase II clinical trials in patients with osteo arthritis, diabetes mellitus — type 2, 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 had received approval from DCGI for phase I/II clinical trial for acute myocardial infarction and critical limb ischemia in March 2009.
Commenting on the approval, BN Manohar, chief executive officer, Stempeutics Research, said, “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 upscaling of mesenchymal stem cells and we expect that it will be the most cost effective product globally.”
The company got the clearance for the first-of-its-kind stem cell product developed in India in almost 15 months. DCGI referred the proposal to Indian Council for Medical Research which constituted an expert stem cell committee for examination. The committee accepted the study as phase II clinical trials.
The trial will begin in April in hospitals in Delhi, Kochi and Bangalore. Patients with osteo arthritis, diabetes mellitus — Type 2, liver cirrhosis and chronic obstructive pulmonary disease, will be given stem cell therapy for six months following which they will be kept under two months of observation.
The results will be analysed subsequently.
The two city hospitals associated in the trial run are MS Ramaiah Hospital and Bhagwan Mahaveer Jain Hospital. “Stem cells are already in use in medical science for various options. In MS Ramaiah Hospital, the clinical trial will be on joint pain or osteoarthritis. This disease is very common in India and after 50 years of age almost every woman gets affected by osteoarthritis. The treatment options till date includes exercises, physiotherapy, painkillers, injections and surgery,” said Dr Naresh Shetty, medical superintendent, MS Ramaiah Hospital.
Mahaveer Jain Hospital was not available for comment on the development.
