A Prospective, Single-center, Open-label Case Series Evaluating the Clinical Outcomes of Lyopreserved Placental Membrane Containing Viable Cells in the Treatment of Chronic Wounds.

Introduction. Cryopreserved placental membrane containing viable cells (vCPM) in conjunction with standard of care (SOC) has shown clinical effectiveness in several studies for the management of acute and chronic wounds. Recently, a new lyophilization technique has been developed that allows viable tissues to be stored at room temperature as a structural and functional equivalent to vCPM. Objective. This case series evaluates the clinical outcomes of a lyopreserved placental membrane containing viable cells (vLPM) for the management of chronic wounds of various etiologies. Materials and Methods. Eleven patients (11 wounds: 5 diabetic foot ulcers, 5 venous leg ulcers, and 1 pressure ulcer) received weekly vLPM applications adjunct to SOC. Results. By week 12 of treatment, 63.6% (7/11) of patients achieved complete wound closure, with a mean time to closure of 47.1 days and a mean of 6 vLPM applications. Further, there were no adverse events attributed to vLPM. Conclusions. This is the first case series reporting the clinical outcomes of vLPM for the management of chronic wounds. Results of this study demonstrate similar closure rates to those previously reported for vCPM. These results suggest potential clinical equivalence between the 2 formulations, with vLPM providing the added convenience of long-term room-temperature storage (current shelf life of 12 months).