Stempeutics Research Private Limited (SRPL) has now commenced the clinical trials with its Investigational Products (IP) to treat Acute Myocardial Infarction (AMI) and Critical Limb Ischemia (CLI).The placebo controlled double blind studies are being conducted at five locations in the country at Bangalore, Kochi, Hyderabad, Ahmedabad and New Delhi.

The IP which is being administered intravenously was developed by Stempeutics using the Mesenchymal stem cells sourced from healthy donors. The effort makes it the first company in the country along with a handful of companies globally to aggressively work towards developing the much-awaited maiden stem cell drug.

Stempeutics has a large scale GMP complaint facility where around 200 packs were produced using a novel up-scale process.

"Going by positive response on the study which has taken off so far, we are looking at a product launch by early 2011. We have allocated a trial period of 8 months for the ongoing phase-I and phase-II. After which we will immediately slate the phase-III, BN Manohar," president Stempeutics Research Pvt. Ltd told Pharmabiz.

There is a huge market opportunity with these products. It is estimated that 35 lakh people suffer from Acute Myocardial Infarction and 10 lakh patients are diagnosed for Critical Limb Ischemia. The Indian market for the Mesenchymal stem cells product to treat CLI condition is valued at Rs 250 crore and for AMI it is Rs 500 crore. Globally the Stem cell product market is expected to be $10 million industry by 2015.

Presently there are 10 stem cell dedicated companies in the country including Stempeutics, part of the Manipal Group and Reliance Life Sciences. The research centres are Centre for Cell and Molecular Biology (CCMB), Hyderabad, LV Prasad Eye Institute, Hyderabad, All India Institute of Medical Sciences, New Delhi CMC, Vellore to name a few.

"Our drug for both conditions will provide the much-needed affordability in terms of cost for the patients. What drives the company's assertion towards a successful final drug is its sound and solid research undertaken via in-vitro studies. We are also hoping for a positive outcome with the human studies too. There is a considerable interest among the patients also to undertake the trial," said Manohar.

Globally, there are four companies undertaking the human studies. One of them is the US-based Osiris Therapeutics Inc. with its product Prochymal treat acute Graft vs. Host Disease which is an immunity disorder affecting bone marrow transplant cases, reported OTI sources.

Stempeutics has a team of doctors and dedicated researchers working on stem cells for the last few years. While it will definitely be the first company in India to launch the stem cell drugs to treat AMI and CLI conditions, globally it could also be one of the companies to launch the product in the next 20 to 24 months. "The product which will first be introduced in India could also be simultaneously launched in Malaysia, Singapore and Australia where it is working to see the opportunity. We are looking at a cost-effective and affordable therapy to treat scores of patients who are affected with MI and CLI," stated the Stempeutics president.