Comparing the Efficacy of Viable Cryopreserved Placental Membrane for the Treatment of Wounds of Diverse Etiologies

Abstract

INTRODUCTION AND OBJECTIVES: The benefits of using amniotic tissue in skin regeneration are well documented. Today, cryopreservation technology allows for better availability and maintenance of mesenchymal stem cells. This is of particular interest in treating the diabetic foot ulcer as this population has fewer mesenchymal stem cells. The objective of this case series investigation was to compare the efficacy of cryopreserved human amniotic stem cells in treating foot wounds of different etiologies. We will present data and case photos for a diabetic foot ulcer, venous leg ulcer, arterial ankle ulcer, and a pyoderma gangrenosum ulcer. METHODS: Cryopreserved human amniotic stem cell grafts were applied to patients with chronic ulcers of different etiologies that had been subjected to at least 4 weeks of standard wound care and did not show adequate clinical progress. Wound area was recorded and photographed on weekly basis. Area reduction was charted over time and the results of each individual case were compared to one another. RESULTS: All ulcers displayed results that well exceeded the established parameters of weekly healing rates for effective wound treatment modalities. • Pyoderma gangrenosum displayed the poorest response to treatment. However, it is worth noting that the patient was not compliant in the prescribed adjunctive treatment regimen but managed to achieve 64% wound reduction. • All ulcers showed the largest appreciable amount of healing in both total area reduction and week-to- week closure percentage after the first application. CONCLUSIONS: Cryopreserved human amniotic stem cell grafts can aid in the decreasing the time to closure of various types of lower extremity ulcerations. The therapy is a clinically viable option for physicians to consider when formulating a treatment plan for a patient with an ulcer.

Introduction

The rate of successful healing of skin ulcerations is inversely proportional to the the time it takes to achieve primary closure and thus the objective of treatment should be to achieve primary closure as soon as possible to prevent infection and limb loss. Mesenchymal stem cells (MSCs) play a vital role in all phases of the wound healing process [1]. (Figure 1)

Recent developments in biotechnology have allowed physicians to harness the innate properties of MSCs and apply them in a treament modality focused on increasing epithelialization by decreasing production of inflammatory cytokines and increasing angiogenesis by applying Viable Cryopreserved Placental Membrane (vCPM). The benefits of using vCPM in wound healing are well documented [2,3].

However, many of these studies evaluate the efficacy of of the therapy for treatinf diabetic foot ulcers and venous leg ulcers with wound of other etiologies grouped into an “other” category. The purpose of this case series was to evaluate vCPM in treating wounds of specific etiologies and compare the results to a diebetic foot ulcer and and each other.

Methods

vCPM grafts were applied to patients with varying ulcer etiologies in accordance with the manufacturer’s guidelines and standard of care for each specific wound. The wound area was measured and recorded weekly. Area reduction was cahrted over time and the progress was compared to each other wound.

Discussion

• All ulcers displayed results that well exceeded the established parameters of weekly healing rates for effective wound treatment modalities.[4]
• Pyoderma gangrenosum displayed the poorest response to treatment. However, it is worth noting that the patient was not compliant in the prescribed treatment regimen of using a lymphedema pump twice daily as a co-therapy to the cHMA. The treatment failed to produce a reduction in wound area after all applications but managed to achieve 64% wound reduction in a lesion that had not responded to over a year of treatment using other modalities.

• All ulcers showed the largest appreciable amount of healing in both total area reduction and week-to-week closure percentage after the first application.

Conclusion

What this Study Adds:

• Documented cases of vCPM as an effective treatment for wounds other than DFU.
• vCPM was effective reducing wound area in wounds that had failed long courses of conservative treatment.
• vCPM is effective in treating pyoderma ganrenosum, but adjunctive treatment may be necessary for optimal results.