Manipal Group cleared to begin trials on stem-cell based drugs

Stempeutics Research Pvt Ltd, a group company of Manipal Education and Manipal Group, is planning to launch two stem-cell based drugs by 2011 — one for treating heart attack patients and another for the treatment of limb complications in patients with critical limb ischemia (CLI).

The Rs 50 crore Bangalore-based company announced on Tuesday it has received clearance from the Drugs Controller General of India for conducting clinical trials for these drugs. Trials will be conducted across India on about 200 patients in cities including Bangalore, Hyderabad, Delhi and Thiruvananthapuram.

“Based on the successful outcome of the clinical studies, we plan to introduce these stem cell-based drugs in India by the end of 2011,” said

B N Manohar, president, Stempeutics. “It will be the first-of-its kind clinical trial of stem cell-based drug in India,” he added.

Stem cells are the master cells of the human body. They can divide to produce copies of themselves and many other types of cell. They are found in various parts of the human body at every stage of development from embryo to adult. Because stem cells are so versatile, they could potentially be used to repair and replace damaged human tissue.

The purpose of experimental stem cell therapy is to offer potential benefits of stem cells, to slow down or stop further deterioration caused by the disease and to see if stem cells can reverse the effects of the disease.

“The stem cells used in our experimental therapy are mesenchymal stem cells, which are derived from the bone marrow of healthy volunteers. These are multipotent stem cells that can transform into a variety of cell types, and thereby help in regeneration and repair of the diseased tissues,” said Dr Nagendra Swamy, COO, Manipal Hospital and group director, Medical Services, Manipal Health Systems.

The stem cell-based drug, if injected into a patient who has had a heart attack, can help regenerate the dead heart muscles. In patients with CLI, who often need amputations caused by non-healing wounds and gangrene, a stem cell-based drug can help repair the blood vessels in the legs, he said.

Apart from the initial funding of Rs 50 crore, the company, which was set up in 2006, is planning to spend an additional Rs 70 crore on R&D in the next couple of years.

“While initial funding was arranged within the Manipal Group, for the extended investment plans and also for marketing the drugs in countries across the globe, we are looking for a strategic partner,” said Manohar. “The partner will preferably be a pharmaceutical company, either an Indian player or an international company,” he added.

Nagendra Swamy said the global market for stem cell therapies is estimated to be $20 billion by 2010. In India, the size of the market is about $540 million and is expected to grow rapidly. “It is essential to come out with innovative production techniques for upscaling and make therapy affordable,” he said.