Cipla has invested Rs 50 crore into Stempeutics Research Pvt Ltd (SRPL), a part of the Manipal Education & Research Group for R&D and marketing of the first stem cell product Stempeucel for treating Critical Leg Ischemia (CLI). This product will be ready in 2013 after its ongoing phase-III study.
The Bangalore-based Stempeutics has received the DCGI consent for carrying out clinical trails on 120 patients at hospitals across the country in late 2009. The 'Stempeucel' has been manufactured at its GMP complaint facility in Bangalore for phase-III study. The outcome of the phase-I and phase-II studies have established the safety of the product developed. "We need to further establish the efficacy of 'Stempeucel," BN Manohar, president, SRPL said at press conference.
The product is developed using mesenchymal stem cells derived from donated bone marrow. In India, CLI prevalence is 1,000 per one million population. Going by the high incidence of the condition known to affect young and productive population, SRPL was keen to find an alternative therapy using stem cells, he added.
The outcome of the phase-I and II studies have proved that there is no rejection of allogenic or mesenchymal stem cells. No adverse events were reported. There was improvement in ankle brachial pressure index (ABPI) and ankle pressure with decrease in number of ulcers no increase in amputation need. Going by the positive outcome so far, SRPL has teamed up with Cipla to take on production upscale at its GMP and international regulated plants apart from marketing it across pan India and globally.
According to Dr Jaideep Gogtay, medical director, Cipla, under this alliance, we will support SRPL for R&D of stem cell based products. Further investment may be considered too.
With regenerative medicine rapidly emerging area of biomedical research and stem cells becoming a major branch of treatment to be recommended soon as a standard of cure, 'Stempeucel' will be used as a single dose and can prevent amputation of the limb. The product is stored in 190 degree centigrade and dosage is decided based on the patient's body weight.
Meanwhile Stempeutics has three facilities, two in India at Manipal and Bangalore and one at Malaysia with seven products in the pipeline. Its product for acute myocardial infraction also is in the advanced stages of human studies and the trial result is expected in August this year and will be launched in 2013 from India. For osteoarthritis and cerebral stroke, it is conducting research and trials from Malaysia. It is working for regulatory consent on indications like chronic pulmonary disease, dilated cardiomyopathy, liver cirrhosis and diabetes mellitus.
Market for adult stem cell therapy in India is valued at US$ 540 million. Adult stem cell constitute 58 per cent of the global stem cells market. Stem cells is the next sought after solution in regenerative therapies after drugs, stents and surgery.
Currently, Stempeutics will have an edge in the global market if it is able to bring out Stempeucel for CLI. There are five international companies working at various stages of product development. These are the US-based Osiris Therapeutics and Geron, one Israel based company and Australia's Monash Immunology, said Manohar.