Stempeutics Research has completed patient enrollment for Phase III trials of a therapy for non-healing diabetic foot ulcer (DFU).
A group company of Manipal Education and Medical Group (MEMG), Stempeutics is evaluating its Stempeucel-DFU to determine if it can treat non-healing diabetic foot ulcer in patients who do not receive adequate relief from current standard of care therapies. Drugmaker Cipla has in-licensed Stempeucel-DFU to market in the country.
The study is a randomised, double blind, placebo controlled, multicentre, single-dose study assessing the efficacy and safety of peri-ulcer administration of Stempeucel-DFU, the company said. About 84 patients were recruited in this study based on inclusion/exclusion criteria and randomised into either the stemcell arm or placebo arm in a ratio of 1:1, it added. As a result, 42 patients received Stempeucel-DFU drug, and 42 patients received the placebo.
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The drug is administered through intramuscular/intradermal/subcutaneous route based on the location of the ulcer, it said.
BN Manohar, Stempeutics Managing Director and Chief Executive Officer, said, if Phase III results demonstrate durable improvement in ulcer healing, Stempeucel-DFU has the potential to make a major difference in patients with this serious medical condition.
Dr Pawan Gupta, Stempeutics President (Medical and Regulatory Affairs), said, the current standard of care for treating non-healing diabetic ulcer included wound care with sterile dressings, repeated debridement of necrotic tissues and pressure off- loading. “Most results are unsatisfactory, and about 20 percent of patients with DFU undergoe limb amputation.” Cell therapy has its advantages compared to other modes of treatment, as it secretes various cytokines / growth factors that are shown to orchestrate various steps of the wound healing process, he added.
Jaideep Gogtay, Cipla Global Chief Medical Officer, said, “DFU is a serious condition requiring immediate treatment to re-establish blood-flow to the affected area to prevent the leg from amputation.” The novel treatment by Stempeucel-DFU will equip physicians in India to treat DFU and will improve the quality of patient lives, he added.