Stempeutics, part of the Manipal Health Systems, engaged in research and development of human stem cell technology in regenerative medicine, is investing Rs 45 crore on clinical trials in Mesenchymal-Allogeneic stem cells. The company is the only facility in the country which has been audited as a centre for clinical trials by ICMR.

Currently, animal studies are completed and the data which is favourable towards use of stem cell in disease therapies will be submitted to the Indian Council of Medical Research in mid-February for human trials approval. Stempeutics is expected to conduct human studies in March for myocardial infraction (MI), leg ischemia, spinal chord injuries and stroke.

The trials are expected to be completed by March 2008 and the data will be submitted to the ICMR and Drugs Controller General of India (DCGI) for clearance to produce Allogeneic stem cell products for the treatment of MI and leg ischemia which will be made available by the end of 2008. Thereafter Stempeutics will work on products for spinal chord injuries and stroke.

The Allogeneic stem cell products will be available off the shelf at Stempeutics for hospitals across the country. "This will be a major achievement in the country's medical treatment option," Dr Satish Totey, chief scientific officer, Stempeutics told Pharmabiz. "The stem cell trials and products will be a first time in the country initiative," he added.

The company has worked on Autologous stem cells and completed pre-clinical and pilot studies. Similar trials were conducted globally by many other companies but the randomized trial results showed variations in efficacy. Treatment with Autologous stem cell is expensive. Therefore, Stempeutics decided to opt for Allogeneic because it proved to be inexpensive, safer and beneficial in prolonged disease-free survival and relapse rate. The cost of Autologous stem cell transplant is around Rs 2 lakh to 3.5 lakh and using Allogeneic cells would be around Rs 35,000 per procedure.

The Allogeneic products for MI, leg ischemia, stroke and spinal chord injuries will be manufactured at Stempeutics on a large scale in the cell factories. These stem cell products will be packed in cryobags, Dr Totey said.

Stempeutics is also working on stem cell based assays for drug screening and toxicity studies, thus, providing predictive efficacy and safety values. Stempeutics can offer such services to the pharma-biotech companies. "Such value-added products will help save time in drug developments," Dr Totey said.

Meanwhile, the Manipal Institute of Regenerative Medicine (MIRM) under Manipal University which is currently providing doctoral programmes (PhDs) in Regenerative Medicine at Manipal will also start an Institute here in Bangalore to offer Post Graduation in Regenerative Medicine for the first time in the country. The two-year programme of four semesters approved by the University Grants Commission (UGC) will start in June 2007 with 50 seats. This will allow us to have trained personnel for our future projects and product development efforts, Dr Totey said.

MIRM has already inked a pact with Stempeutics for commercialization of stem cell products.

By 2009, the company will set up its own campus in Bangalore to consolidate its operations at one facility, added Dr Totey.