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.

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.

Prospective, Single-center, Open-label, Pilot Study Using Cryopreserved Umbilical Tissue Containing Viable Cells in the Treatment of Complex Acute and Chronic Wounds.

INTRODUCTION: Complex wounds with exposed bone, muscle, tendon, or hardware continue to be a therapeutic challenge for wound care providers. Wounds with exposed structures are more susceptible to infection, necrosis, and amputation. As such, rapid granulation to cover exposed deep tissue structures is essential for patient recovery. OBJECTIVE: In this prospective, pilot study, the authors evaluate the clinical outcomes of a cryopreserved umbilical tissue graft containing viable cells (vCUT) in the treatment of complex wounds. MATERIALS AND METHODS: Ten patients with 12 wounds each received 1 application of vCUT. Two patients did not complete the study and were removed from the per-protocol population. Data analyses were performed on the remaining 8 patients with 10 wounds. The average wound area was 16.5 cm2 with an average duration of 10 months. Post-application, patients were followed for an additional 4 weeks for granulation, closure, and safety outcomes. RESULTS: By the end of the study, 8 of 10 (80.0%) vCUT-treated wounds achieved 100% granulation, and 3 wounds (30.0%) went on to achieve complete closure. The median area reduction was 40.5% and the median volume reduction was 59.4%. CONCLUSIONS: The results of this study suggest vCUT in conjunction with standard of care can be a viable treatment option for acute and chronic lower extremity complex wounds.

Management of a complex scalp defect with cryopreserved placental membrane containing viable cells resulted in rapid wound closure.

Reconstructive methods are most commonly used to treat scalp defects. However, patients with complex defects are often not good candidates for surgical procedures due to the severity of the wound, advanced patient age, and multiple comorbidities. In these instances, alternative nonsurgical advanced therapies should be considered.

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

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.

Management of a chronic radiation necrosis wound with lyopreserved placental membrane containing viable cells.

This case report describes management of a chronic radiation wound in a patient with multiple comorbidities using a lyopreserved placental membrane containing viable cells (vLPM). Positive outcomes suggest that vLPM provides a good conservative management option for patients with compromised wound healing due to radiation and comorbidities.

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).

A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers.

Randomized controlled clinical trials, the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers in comparison to standard of care. However, randomized controlled clinical trials comparing efficacy between two or more skin substitutes are very limited. With growing numbers of new skin substitutes, such studies are essential for treatment and policy-making decisions by wound care providers and payers. In this study, we analyzed clinical outcomes and product cost between a viable cryopreserved placental membrane (vCPM) and a human fibroblast-derived dermal substitute (hFDS) for the treatment of chronic diabetic foot ulcers in a prospective, multicenter, single-blind study. The outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group and 31 patients in the hFDS treatment group. Utilizing a non-inferiority trial design and the established treatment regimen of 8 applications for hFDS, we demonstrated that vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% CI: [10.67, 28.94]). However, preliminary findings show that vCPM may have better outcomes for wounds ≤ 5 cm2 : 81.3% (13/16) of wounds in the vCPM group vs. 37.5% (6/16) of wounds in the hFDS group reached complete closure at the end of treatment (p = 0.0118). A preliminary product cost analysis for wounds ≤ 5 cm2 may show significant savings for patients treated with vCPM. Average per-patient costs during the course of treatment were $3,846 and $7,968 (p < 0.0001) for vCPM and hFDS patients, respectively. These results may be used as guidance to wound care providers and payers.