Stempeutics Research, a group company of Manipal Education & Medical Group, announced that Drug Controller General of India (DCGI) has granted clearance of the company’s investigational medicinal product 'stempeucel' for conducting phase II clinical trials in patients with critical limb ischemia (CLI) caused due to Buerger’s disease. This trial is non-randomised, open labelled, multi-centric and dose finding study.

Earlier Stempeutics has completed the phase I part of the trial approved by DCGI and based on the outcome of phase I trial–DCGI has granted clearance of phase II trial. 'Stempeucel' product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology.

A total of 126 patients will be recruited across 10 hospitals and all the patients will be followed up for two years after the injection of stempeucel. This CLI trial will be conducted in some major cities such as Delhi, Chennai, Bangalore and Kolkata. Upon successful completion of phase II trial, phase III is expected to be launched by early 2013· the company informed that its goal is to launch 'stempeucel' product in the Indian market by the end of 2014.

Buerger’s disease is a non-atherosclerotic segmental inflammatory disease that most commonly affects young male heavy smokers. This disease is predominantly seen among people of low socioeconomic class who smoke bidis. Incidence of CLI is estimated to be approximately 50 to 100 patients per lakh per year and 10 - 40 per cent of them are at the risk of primary amputation. The prevalence of the Buerger’s disease among all patients with CLI varies from as low as 0.5 to 5.6 per cent in Western Europe to as high as 45 to 63 per cent in India. Patients with CLI have a one and ten year mortality of approximately 20 per cent and 75 per cent respectively.

It is expected that 'stempeucel' may possibly address the issues related to this disease. When injected by the intramuscular route in the affected limb, it can lead to formation of new blood vessels or neo-angiogenesis. This in turn may relieve the rest pain, heal the ulcers and prevent amputation. In this phase II trial, a total of 126 patients will be recruited at study centres across India.