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

Eric L. Johnson, MD; Molly Saunders, BS; Tanushree Thote, PhD; Alla Danilkovitch, PhD

Disclosures

Wounds. 2021;33(2):34-40. 

In This Article

Abstract and Introduction

Abstract

Introduction: 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) vs SOC alone; however, data for other types of wounds are limited.

Objective: This study aimed to evaluate the clinical outcomes of amnion-derived and chorion-derived cryopreserved placental membranes containing viable cells (vCPM) in the treatment of nonhealing upper-extremity and lower-extremity wounds of nondiabetic and nonvenous pathophysiology. The authors hypothesized that treatment with vCPM adjunct to SOC would result in positive clinical outcomes for these wounds.

Materials and Methods: 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 diabetic and 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).

Results: 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-extremity and lower-extremity wounds, nor between the amnion and chorion products. There were no vCPM-related adverse events.

Conclusions: This study provides valuable information to physicians, hospitals, and payers as it pertains to medically necessary and appropriate patient treatment.

Introduction

Nonhealing wounds affect approximately 2% of the US population, with the majority of patients affected being at least 65 years of age.[1] In an analysis of a 2014 Medicare database, wound prevalence among beneficiaries was determined to be nearly 15%. Of these, the most prevalent types of wounds were surgical and traumatic. However, the majority of published clinical studies have evaluated wound closure outcomes for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), and there is a lack of data for the more prevalent types of wounds (ie, surgical and traumatic).[2]

Nonhealing wounds continue to present a therapeutic challenge to physicians. Typical standard of care (SOC) for such wounds includes thorough evaluation of systemic issues that may affect wound healing, cleansing and debridement, maintenance of a moist wound environment, infection and biofilm management, nutritional support, and offloading and/or compression dependent on wound location. For burns specifically, hemodynamic resuscitation, pain control, prevention of scarring, and rehabilitation are also part of the SOC regimen.[3]

For difficult-to-heal wounds, typically in patients with significant comorbidities, SOC alone is not enough to achieve closure.[4] Subsequently, advanced therapies such as skin substitutes are often recommended for use adjunct to SOC.[5,6] One such skin substitute is cryopreserved placental membrane containing viable cells (vCPM). A vCPM allograft is a cryopreserved placental membrane, derived from amnion or chorion, that retains the extracellular matrix, growth factors, and endogenous neonatal cells, including mesenchymal stem cells of the native tissue.[7,8] The main difference between the 2 products is that vCPM-amnion contains an epithelial layer, whereas the vCPM-chorion does not.

Previously, positive clinical outcomes with the use of vCPM have been demonstrated in various DFU and VLU studies. In 2013, a retrospective single-center study showed an 85.2% closure rate for 27 chronic DFUs and a 67.6% closure rate for 34 chronic VLUs when vCPM-amnion was used adjunct to SOC.[9] In a multicenter, prospective, randomized controlled trial of 97 total patients, Lavery et al[10] demonstrated a 62% closure rate in the treatment of chronic DFUs using vCPM-amnion adjunct to SOC with a faster time to closure compared to SOC alone. In a retrospective analysis of 350 chronic DFUs in a real-world setting, Raspovic et al[11] showed a 59.4% closure rate by the end of treatment using vCPM-amnion and vCPM-chorion. Lastly, Farivar et al[12] showed a 53% closure rate in 30 chronic VLUs with vCPM-amnion treatment after failing 12 weeks of standard therapy.

With published vCPM data for DFU and VLU studies demonstrating safety and efficacy, vCPM coverage for these types of wounds among different payers is fairly widespread. The use of vCPM in the treatment of other wound types is considered investigational and is not considered medically appropriate due to lack of clinical evidence. However, vCPM has been used in the treatment of other types of wounds. Based on previously published data, the authors hypothesized that positive clinical outcomes would be seen in the treatment of nonhealing upper-extremity and lower-extremity wounds of nondiabetic and nonvenous pathophysiology with vCPM adjunct to SOC.

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