Cell Therapy Trial for Diabetic Foot Ulcer (DFU) Completes Patient Enrollment

Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today that enrollment has completed in the Phase 3 clinical trial 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. A total of 84 patients were recruited in this study based on inclusion/exclusion criteria and randomized into either stem cell arm or placebo armin a ratio of 1:1. Thus 42 patients receivedStempeucel®-DFU drug and 42 patients received placebo.
Dr. Jaideep Gogtay, Global Chief Medical Officer, Cipla said, “The novel treatment by Stempeucel®-DFU will equip physicians in India to treat DFU and will lead improved quality of life for thousandsof patients”.