India's first stem cell trial to take place in Bangalore

The Drugs Controller General of India (DCGI) has given permission to a Bangalore-based company, Stempeutics Research, for carrying out Phase-II clinical trials to find out the efficacy of stem cell therapy. The safety of “Stempeucel” was established in an earlier trial. “The trial will begin in April in Bangalore, Delhi and Kochi in association with hospitals. Patients will be given the stem cell therapy for six months. The results will be analysed subsequently and patients will be under observation for two years,” B N Manohar, chief executive officer of Stempeutics told Deccan Herald.

If successful, stem cell therapy may possibly result in permanent cure for chronic diabetes, killer alcoholic liver cirrhosis and chronic obstructive pulmonary disease (COPD).
COPD leads to gradual destruction of lung tissues making breathing difficult for a person. The therapy will also take care of crippling osteoarthritis. All of them are at present incurable. Stem cells used in the therapy are called “mesenchymal stem cells”(MSC), derived from the bone marrow of healthy donors using a proprietary technology. In the last decade, stem cells opened up a new therapeutic window as they can produce almost all types of cells in the body. There are two categories of stem cells. The first one can be harvested from embryos and the second one from adult bone marrow and umbilical cord blood. MSC is produced from bone marrow.

The company has roped in M S Ramaiah and Mahaveer Jain hospitals in Bangalore, and Medanta Medicity in Delhi for the clinical trial.

For liver cirrhosis, the therapy would be tried on 60 patients, whereas for diabetes the trial will involve about 45 patients. In case of osteoarthritis and chronic obstructive pulmonary disease – the therapy would be tested on 30 patients each. The stem cells kept in a cryo-bank, will be injected into the patients. In case of COPD and diabetes it will be intravenous shots whereas in osteoarthritis, it will be intra-articular injection. Only one shot is given to the patients.

Being the first stem cell trial in the country for as many as four ailments, the DCGI took almost 15 months to review the proposal and grant permissions.  Its safety was tested in a smaller trial involving 20 patients each for acute myocardial infarction and critical limb ischemia in March 2009.

“The clinical protocol was referred to an expert panel constituted by the Indian Council of Medical Research. Only after the ICMR panel was satisfied, the DCGI permission came,” said Manohar.

If the trial succeeds, India’s first stem cell product could be expected by 2014-15, said Satish Totey, a researcher, formerly associated with National Institute of Immunology, Delhi. 

The R&D driven company – owned by the Manipal Group and Cipla – is even more ambitious. It expects to bring the first Indian stem cell-based drug in the market by 2013. “Our developments are parallel to research activities in the US and Australia from where the first seven-eight commercial stem cell therapies may be launched by next year,” Totey who used to be associated with Stempeutics Research in the past, told Deccan Herald.