Open-label Venous Leg Ulcer Pilot Study Using a Novel Autolologous Homologous Skin Construct

Abstract

Background: Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment was evaluated in an open-label, single-arm feasibility study to test the hypothesis that AHSC treatment will result in wound closure by providing healthy autologous tissue to the wound bed. Methods: Ten VLUs were treated with a single application of AHSC. A 1.5 cm2 full-thickness skin harvest from the proximal calf was collected and sent to a Food and Drug Administration–registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound and dressed with silicone. The primary endpoint was wound closure rate at 12 weeks. Wound closure was followed with 3-dimensional planimetry, and closure was confirmed by a panel of plastic surgeons. Additional endpoints followed for 12 weeks included graft take, harvest site closure, adverse event rate, complications, and patient-reported pain. Results: All 10 VLUs demonstrated successful graft take as evidenced by graft persisting in wound and harvest site closure. Eight VLUs exhibited complete closure within 12 weeks. One VLU that failed to heal with a prior split thickness skin graft closed within 13.5 weeks with AHSC. The mean time of closure was 34 days (95% confidence interval, 14–53). Pain improved by closure confirmation visit. There was 1 serious adverse event unrelated to the product or procedure. Conclusion: This pilot study demonstrated that AHSC may be a viable single-application topical intervention for VLUs and warrants further investigation in larger, controlled studies.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis

“…Multiple studies support the safety and efficacy of a novel autologous heterogeneous skin construct (AHSC) as adjunctive therapy used on complex and chronic wounds. [8][9][10][11][12][13][14][15][16][17][18] The AHSC is manufactured from a small autologous harvest of the patient's full-thickness, healthy skin, containing the skin's natural endogenous regenerative cellular populations that facilitate healing. [13][14][15][16][17]19 Within just a few days of harvest, the AHSC is processed by an external facility, returned to the provider and applied to wound in the outpatient setting.…”

“…Small skin islands form rapidly across the wound bed that increase in size and coalesce together to promote complete and uniform epithelialization. 8,9 Recently, an interim analysis was published of the first 50 of 100 patients that enrolled in this randomized controlled trial (RCT) that compared the effects of AHSC to standard of care (SOC) in the treatment of Wagner 1 DFUs. 18 The interim data demonstrated a strong healing effect in favour of AHSC, which closed significantly more DFUs at 12 weeks compared to the SOC control group (18/25, 72% vs. 8/25; 32%, p = 0.005).…”

A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis

“…A novel autologous heterogeneous skin construct (AHSC) created from a small harvest of full thickness, healthy skin may be safe and effective as adjunctive therapy in treating complex and refractory wounds 15‐24 . AHSC is composed of small multicellular segments and contains the endogenous regenerative cellular populations of healthy skin that promote wound closure, so that a single application can regenerate full‐thickness, functionally polarised skin on the wound bed 20‐25 .…”

“…A novel autologous heterogeneous skin construct (AHSC) created from a small harvest of full thickness, healthy skin may be safe and effective as adjunctive therapy in treating complex and refractory wounds. [15][16][17][18][19][20][21][22][23][24] AHSC is composed of small multicellular segments and contains the endogenous regenerative cellular populations of healthy skin that promote wound closure, so that a single application can regenerate full-thickness, functionally polarised skin on the wound bed. [20][21][22][23][24][25] The manufacturing process of the AHSC retains the endogenous regenerative cellular populations associated with wound healing present within hair follicles, glands, and the interfollicular epidermis, facilitating engraftment optimisation and wound closure.…”

Autologous Heterogeneous Skin Construct Closes Traumatic Lower Extremity Wounds in Pediatric Patients: A Retrospective Case Series

“…1,5 An autologous heterogeneous skin construct (AHSC) has become available in recent years that has demonstrated the regeneration of full-thickness skin with follicles and glands. [6][7][8][9][10][11][12][13] AHSC utilizes a small, elliptical full-thickness skin harvest from the patient that can be closed primarily. The autologous donor skin is shipped to a biomedical manufacturing facility where it is manufactured into AHSC and can be returned for application to the wound bed as early as 48 hours after harvest and is viable for use for up to 14 days after harvest.…”