Cryopreserved Placental Membranes Containing Viable Cells Result in High Closure Rate of Non-Healing Upper and Lower Extremity Wounds of Non-Diabetic and Non-Venous Pathophysiology

Higher closure rates for chronic diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) have been reported for placental products adjunct to standard of care (SOC) versus SOC alone; however, data for other types of wounds are limited. The purpose of this study was to evaluate the clinical outcomes of amnion- and chorion-derived cryopreserved placental membranes containing viable cells (vCPM*) in the treatment of non-healing upper and lower extremity wounds of non-diabetic and non-venous pathophysiology.

Data for all patients consecutively treated between January 2016 and May 2019 with vCPM adjunct to SOC were retrospectively collected and analyzed through chart review at a single center. Patients with wounds of non-diabetic and non-venous pathophysiology and patients receiving other skin substitutes during the course of vCPM treatment were excluded from the study. Outcomes included wound closure, time to closure, number of applications, and vCPM-related adverse events (AEs).

Ninety-two patients with 104 wounds received vCPM applications adjunct to SOC. The median wound size was 3.15 cm2 (mean 12.7 cm2) with a median duration of 1.5 months (mean 3.9 months). Eighty-seven of the 104 wounds (83.7%) achieved complete wound closure in a median time of 41 days and 3 applications of vCPM. There were no differences in closure rates between upper and lower extremity wounds, nor between the amnion and chorion products. There were no vCPM-related adverse events.

This is the first large retrospective analysis of clinical outcomes utilizing vCPM, a placental tissue allograft type of skin substitute, for non-DFU and non-VLU wounds. Outcomes suggest that the use of vCPM may be beneficial in the treatment of non-healing upper and lower extremity wounds of non-diabetic and non-venous pathophysiology. This study provides valuable information to physicians, hospitals, and payers as it pertains to medically necessary and appropriate patient treatment.

Trademarked Items (if applicable): *vCPM – Grafix PRIME®, GrafixCORE® Osiris Therapeutics, Inc., Columbia, MD

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