Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells.

Charles E Ananian,Matthew J Regulski,Alexander M Reyzelman,Eric L Johnson,Alla Danilkovitch,Molly C Saunders,R Daniel Davis

doi:10.1089/wound.2019.1028

Abstract

Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM).Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs).Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of ≤12 and >12 months duration, respectively. There were no AEs related to vLPM application.Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting.Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

Highlights

Chronic or nonhealing wounds are defined as wounds that are unable to proceed through the normal phases of healing in a timely and orderly manner.[1]
This study shows positive clinical outcomes with vLPM use for nonhealing wounds of different etiologies and locations, and shows wound closure rates similar to those previously reported for vCPM
Ninety-six point nine percent of wounds were located on the lower extremity and 3.1% were nonlower extremity wounds located on the tailbone, scrotum, and shoulder

Summary

Introduction

Chronic or nonhealing wounds are defined as wounds that are unable to proceed through the normal phases of healing in a timely and orderly manner.[1]. Current standard of care (SOC) for nonhealing wounds typically includes cleansing and debridement of necrotic and infected tissue, establishment of adequate circulation, maintenance of a moist wound environment, nutritional support, infection management, and offloading or compression depending on wound location and etiology.[4] in patients with significant comorbidities, SOC alone often is not sufficient for wound management. As a result, advanced adjunctive therapies are recommended for these difficult-to-heal wounds. One class of advanced wound-care therapies, include different categories, such as bioengineered matrices, xenografts, and tissue allografts. Human placental membranes have a long history in wound management.[5,6] Recently, with advances in preservation technologies, many different placental tissue allografts have become commercially available, including a cryopreserved placental membrane containing viable cells (vCPM).[6,7]

Methods

Results

Conclusion