Bangalore: In a development that could take stem cell treatment closer to the market, Stempeutics Research Pvt. Ltd has completed the first two stages of clinical trials to treat critical deficiencies of blood supply to limbs by using stem cells from bone marrow.
The Manipal group-promoted Stempeutics said on Tuesday that it aims to market the therapy by early 2013.
The firm also announced a strategic alliance with drug maker Cipla Ltd, which will sponsor research and development worth up to Rs50 crore and provide technical support to produce and commercialize the treatment. In return, Cipla will get marketing rights of products developed at Stempeutics.
Applied research: Stempeutics president B.N. Manohar (left) and Cipla’s Jaideep Gogtay with the stem cell product, STEMPEUCELcli.
Presenting data from year-long clinical trials on 20 patients of critical limb ischemia (CLI), Stempeutics president B.N. Manohar said his company has now sought approval for the last phase of the trial from the Drug Controller General of India.
CLI is a chronic condition with pain, ulcers or gangrene in the limbs owing to reduced blood flow. It affects 1,000 people in every million of India’s population, leading to amputation in 10-40% cases.
“We have proven safety; primary and secondary efficacy data is also very encouraging,” Manohar said. “The stem cells are well tolerated by the body.” The next study on a larger sample will throw more light on the efficacy, he added.
Stem cells have the potential to multiply indefinitely and become many different cell types. They are now being derived from a variety of sources such as skin, bone marrow, intestine and dental pulp, but the rapidity at which these sources have been discovered hasn’t quite matched biomedical advances. As a result, therapies are still experimental.
With the latest CLI data, Stempeutics joins a select band of companies globally that are conducting advanced stages of stem cell trials. Stempeutics will be ready with similar data for heart attacks, or acute myocardial infarction (AMI), in July.
Reliance Life Sciences Pvt. Ltd (RLS) began offering stem cell treatment for AMI in October. “Given that we have a centralized cell processing model, it is available to any hospital which wants to provide the treatment,” said RLS president K.V. Subramaniam.
However, there’s a difference between the approaches of RLS and Stempeutics. RLS offers so-called autologous therapy, under which stem cells are derived from the bone marrow of the patient.
Stempeutics intends to offer allogenic therapy, where a patient can take stem cells from donors. “We have perfected the technology (of growing, harvesting and shipping stem cells) so that a handful of donors can help produce stem cells for treating a few hundred thousand patients,” said Manohar.
Stempeutics, which has a subsidiary in Malaysia, is running trials for cerebral stroke and osteoarthritis (chronic breakdown of cartilage in the joints) in that country and intends to commercialize those therapies by 2014.
“It’s too early to say how the (CLI) treatment will endure in the long run, but we’ve had very good results in the study,” said Sandeep Agarwal, consultant at Sir Ganga Ram Hospital in New Delhi, who was part of the Stempeutics clinical trials.
Stempeutics and Cipla dismissed concerns on the likely high cost of treatment. “Cipla is known for affordable care,” said Jaideep Gogtay, medical director at Cipla.