Stempeutics completes patient enrollment for Phase 3 of cell therapy trial for DFU
Hyderabad: Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), said it has completed patient enrollment for Phase 3 of cell therapy trial for diabetic foot ulcer (DFU).
Stempeucel is administered through intramuscular, intradermal or the subcutaneous route based on the location of the ulcer. Phase 3 trial has been approved by the Drugs Controller General of India (DCGI).
The study is a randomised, double-blind, placebo controlled, multicentre, single dose study assessing the efficacy and safety of peri-ulcer administration of Stempeucel. A total of 84 patients were recruited in this study based on inclusion/exclusion criteria and randomised into either stem cell arm or placebo arm in a ratio of 1:1. Thus 42 patients received Stempeucel drug and 42 patients received placebo. It is being evaluated to determine whether it can heal the non-healing diabetic foot ulcer in patients.
DFU is one of the devastating complications of diabetes. Out of about 70 million diabetics in India, 25% develop diabetic foot ulcers, of which 50% contact infection and require hospitalisation while 20% undergo amputation.
“Current standard of care for treating non-healing diabetic ulcer includes wound care with sterile dressings, repeated debridement of necrotic tissues and pressure off-loading. However, most results are unsatisfactory, and about 20% of patients with DFU undergo limb amputation. Cell therapy has advantages compared to other modes of treatments as it secretes various cytokines or growth factors that are shown to orchestrate various steps of the wound healing process,” said Dr Pawan Gupta, president, medical and regulatory affairs, Stempeutics.
“There is an urgent need to provide an effective treatment for patients suffering from non-healing diabetic foot ulcers. If the Phase 3 results demonstrate durable improvement in ulcer healing, Stempeucel has the potential to make a major difference in patients with this serious medical condition,” Stempeutics chief executive officer Manohar said.
“The novel treatment by Stempeucel will equip physicians in India to treat DFU and will lead to substantially improved quality of life for thousands of patients suffering from this painful disease,” said Dr Jaideep Gogtay, global chief medical officer, Cipla, which has in-licensed Stempeucel product for sales and marketing in India.
