Bengaluru, May 09, 2023: Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today that enrollment has completed in the Phase 3 clinical trial evaluating a single peri-ulcer injection of its proprietary allogeneic mesenchymal stromal cell product candidate Stempeucel®-DFU in patients with Non-Healing Diabetic Foot Ulcer. Drug is administered through intramuscular / intradermal / subcutaneous route based on the location of the ulcer. Phase 3 trial has been approved by DCGI.
Stempeucel®-DFU is being evaluated to determine whether it can heal the non-healing diabetic foot ulcer in patients who do not receive adequate relief from current standard of care therapies. The study is randomized, double blind, placebo controlled, multicentre, single dose study assessing the efficacy and safety of peri-ulcer administration of Stempeucel®-DFU. A total of 84 patients were recruited in this study based on inclusion/exclusion criteria and randomized into either stem cell arm or placebo arm in a ratio of 1:1. Thus 42 patients received Stempeucel®-DFU drug, and 42 patients received placebo.
The primary efficacy endpoints are:
Proportion of patients with complete healing/closure of the target ulcer at any time during the 12-week period with sustained complete closure for 12 additional weeks of follow-up (Time frame: 12+12 = 24 weeks)
Rate of reduction in size of the target ulcer during the 24 weeks of follow-up
The safety end points are:
The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
Assessment of clinical laboratory, ECG parameters and assessment of vital signs
Speaking on the Stempeucel-DFU product, Dr Pawan Gupta, President, Medical and Regulatory Affairs, Stempeutics, said “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 undergoes limb amputation. Cell therapy have several advantages compared to other mode of treatments, as it secretes various cytokines / growth factors that are shown to orchestrate various steps of the wound healing process.”
Mr. B. N. Manohar, Managing Director and Chief Executive Officer, Stempeutics said, “There is an urgent need to provide an effective treatment for patients suffering from non-healing Diabetic Foot Ulcer, a population which is increasing every day. If the Phase 3 results demonstrate durable improvement in ulcer healing, Stempeucel®-DFU has the potential to make a major difference in patients with this serious medical condition.”
Commenting on the development Dr. Jaideep Gogtay, Global Chief Medical Officer, Cipla 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 lead to substantially improved quality of life for thousands of patients suffering from this painful disease.”
About Non-Healing Diabetic Foot Ulcer (DFU):
DFU is a non-healing or poorly healing full-thickness wound, through the dermis, below the ankle in an individual with diabetes. One of the major reasons for chronic diabetic wound is due to faulty wound healing process, whereas a normal wound healing involves an orchestrated interplay between connective tissue formation, cellular activity, and growth factor activation. Alterations in the above physiological activities result in non-healing ulcers. A few recent studies have investigated these physiological alterations to understand wound healing abnormalities in diabetes. Some of the underlying reasons are (a) decreased secretion of collagen resulting in chronic connective tissue complications and delayed wound healing, (b) impaired cellular activity due to hyperglycemia resulting in the transformation of macrophages and decreased proliferation of keratinocytes, and (c) altered secretion or absence of key growth factors in diabetic wound, impairing the wound healing process .
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