Stempeutics Research recently completed enrollment 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 randomised, 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 randomised into either stem cell arm or placebo arm in a ratio of 1:1. Thus 42 patients received Stempeucels-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