Study design
®, CLI, lower extremity CLI, ulcer, atherosclerotic PAD
PAD, ULCER, HYPERSENSITIVITY REACTION
The product stempeucel® is already approved by Indian FDA for indication CLI due to BD. Hence, the present study was planned as a label extension, single-arm, multi-centric, phase III study to assess the efficacy and safety of stempeucel® in patients with CLI due to atherosclerotic PAD in Indian population. The protocol and informed consent were approved by the Indian FDA and institutional ethics committees of all 7 participating sites, and all subjects gave informed consent. The study was conducted as per International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, principles of Declaration of Helsinki, Schedule Y of Drugs and Cosmetic Act, 1945, and Ethical guidelines for biomedical research on human participants, Indian Council of Medical Research (ICMR) 2006 and registered prospectively in Clinical Trials Registry—India (CTRI/2018/06/014436).A total of 24 patients with unilateral lower extremity CLI due to PAD were enrolled into the study. All patients were injected with stempeucel® based on body weight (2 million viable cells/kg body weight) at baseline visit by a qualified physician as 0.6 ml/kg (if 200 million cells bag is used) or 0.8 ml/kg (if 150 million cells bag is used) of the reconstituted product at 40–60 multiple intramuscular injections in the gastrocnemius muscle in a volume of 0.5 or 1 ml per injection, depending on patient weight. Further, 8 million viable cells which are equivalent to 2 or 3 ml (for 200 or 150 million cell bags, respectively) were administered around the ulcer as multiple intramuscular/intradermal/subcutaneous injections based on the location of the ulcer. To decrease the risk of hypersensitivity reaction premedication of injection of 100 mg of hydrocortisone and 45.5 mg of pheniramine maleate was administered within 1 h prior to study drug injection to all patients.