India's s very first government-authorised trials for stem cell-based therapies will commence next month in hospitals countrywide. In a bid to bring affordable,off-the-shelf stem cell products to the Indian market,Bangalore-based biotechnology firm Stempeutics Research will start multi-centre,stem cell-based clinical trials on patients with diabetes,liver cirrhosis,osteoarthritis and chronic obstructive lung disease widely prevalent maladies which affect millions of Indians. The trials will commence in several hospitals,including AIIMS in New Delhi and M S Ramaiah and Mahaveer Jain in Bangalore,with patient-volunteers (60 patients for liver cirrhosis,30 for diabetes mellitus and so on). While unregulated stem cell treatments proliferate dangerously in private clinics and hospitals,these are the first government-authorised trials approved by Drug Controller General. In an optimistic scenario,the first commercial stem cell drug could hit medical stores as early as 2014,says Stempeutics president B N Manohar. The company has even tied up with Cipla to market its products. Stem cells are special self-renewing cells found in certain body parts such as bone marrow,human embryo and umbilical cord that are envisaged as treatments for injured (such as heart muscle or burned skin) and diseased tissue (such as a failing kidney or a malfunctioning liver) because they can regenerate and differentiate into a variety of healthy cells. While stem cells can thus be derived from both adults and embryos,the use of latter is controversial and banned in India. In the Stempeutics trial,volunteers will be injected with a dose of mesenchymal stem cells that have been derived from the bone marrow of healthy donors. When injected directly into the affected body part liver,pancreas,bone or lung these are expected to stimulate the growth of healthy tissue. Stempeutics says its ultimate aim is to market its therapies not just in India but also in Europe and North American markets.
