Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Venous Stasis Leg Ulcers

Introduction: Venous stasis leg ulcers (VLUs) are a significant burden on the worldwide health-care system and are often refractory to standard of care. A novel autologous homologous skin construct (AHSC) using the patient’s dermal regenerative cellular populations was developed to close difficult-to-treat wounds and assessed in a pilot study setting.

Method: Ten VLUs, all being refractory to at least a month of conservative care, were treated with a single application of AHSC. A 1.5 cm² proximal calf harvest of full-thickness skin was collected in the clinic and sent to an FDA-registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound, dressed with silicone, secured with steri-strips, and bolstered with an absorbent foam covered by a triple-layer compression wrap. Healing was documented with digital photography and planimetry during weekly dressing changes.

Results: Wound closure was verified two weeks following initial closure documentation. Ten out of 10 wounds (100%) had complete graft take one week after ASHC application. All VLU wounds demonstrated granulation and progressive epithelialization shorty after AHSC deployment. Nine of 10 wounds (90%) closed within 12 weeks of a single application of AHSC. A 12.2 cm² wound that had been open for 11 months and failed a prior split-thickness skin graft closed in 13.4 weeks after AHSC therapy. All wounds remained closed at two-week durability follow-up. All full-thickness skin donor harvest sites remained closed with minimal morbidity. AHSC successfully closed VLUs refractory to dressing care with a single application in this pilot study, warranting further evaluation with randomized controlled trials.