Safety and efficacy of intramuscular human placenta-derived mesenchymal stromal-like cells (cenplacel [PDA-002]) in patients who have a diabetic foot ulcer with peripheral arterial disease.

"This phase 1, multicentre, open‐label, dose‐escalation study (Clinical Trials Registration: NCT01859117; https://clinicaltrials.gov/ct2/show/NCT01859117) was divided into three periods: a 28‐day screening period prior to treatment initiation to determine patient eligibility; a treatment period that consisted of cenplacel administration on study days 1 and 8; and a follow‐up period that included evaluations on study days 15 and 29 and at study months 3, 6, 9, 12 and 24 (Figure ). Cenplacel (PDA‐002; Celgene Corporation, Summit, NJ, USA) was administered by deep intramuscular injection into the calf of the leg with the index ulcer. The dosage was divided into 15 portions that were injected in three rows of five sites along the calf. All patients received standard‐of‐care treatment (typically included foot hygiene, debridement, antibiotic therapy for infection and offloading) in addition to cenplacel administration. The primary objective was to evaluate safety and determine the maximum tolerated dose (MTD) and dose‐limiting toxicities (DLTs) of cenplacel. The secondary objective was to explore the clinical efficacy of cenplacel, and included changes in ABI and TBI and the number and extent of ulcers. Exploratory objectives included the development of novel biomarkers of tissue repair and immune modulation."