A Prospective, Single-Center, Open-Label Case Series Evaluating the Clinical Outcomes of Lyopreserved Placental Membrane Containing Viable Cells for the Treatment of Chronic Wounds

Purpose: Cryopreserved placental membrane containing viable cells (vCPM*) has shown clinical effectiveness in several clinical studies for the treatment of acute and chronic wounds. Recently, a new lyopreservation technique has been developed for ambient storage of viable tissues. Lyopreserved placental membrane containing viable cells (vLPM**), processed using this new lyopreservation method, can be stored at room temperature. In contrast to vCPM that required specialized ultra-low temperature equipment for its storage. Scientific studies demonstrate that vLPM is equivalent to vCPM. Both vCPM and vLPM retain structural matrix, growth factors and viable cells native to fresh placental tissue. However, clinical performance of vLPM remained to be investigated. In this case series, we evaluated the clinical outcomes of vLPM for the management of chronic wounds of various etiologies. 

Methods and Results: A total of 11 patients received weekly vLPM applications adjunct to standard of care - five diabetic foot ulcers (DFUs), five venous leg ulcers (VLUs), and one decubitus ulcer. By the end of treatment, 63.6% (7 out of 11) of patients achieved complete wound closure, with a mean time to closure of 47.1 days and mean of 6 vLPM applications. Further, there were no adverse events (AEs) attributed to vLPM. 

Conclusion: This is the first case series reporting the clinical outcomes of vLPM for the management of wounds. Results of this study demonstrate similar closure rates to previous studies utilizing vCPM. These results confirm that vLPM and vCPM are two different storage configurations of the same products. vLPM is clinically equivalent to vCPM with convenience of ambient storage.