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 often refractory to standard of care. A novel autologous homologous skin construct (AHSC; SkinTE; PolarityTE, Salt Lake City, UT) using the patient’s dermal regenerative cellular populations was developed to close difficult-to-treat wounds and assessed in a pilot study setting. 

Materials and Methods: Ten VLUs, all refractory to at least a month of conservative care, were 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 a US Food and Drug Administration-registered facility, where it was processed into AHSC and returned to the provider within 48 hours. The AHSC was spread evenly across the wound and then dressed with silicone, secured with adhesive 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. Wound closure was verified 2 weeks following initial closure documentation. 

Results: All 10 wounds (100%) had complete graft take 1 week after ASHC application. All VLU wounds demonstrated granulation and progressive epithelialization shortly after AHSC deployment. Of the 10 wounds, 9 (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 2-week durability follow-up. All full-thickness skin donor harvest sites remained closed with minimal morbidity. 

Conclusions: The AHSC successfully closed VLUs refractory to dressing care with a single application in this pilot study, warranting further evaluation with randomized controlled trials.

*This poster won 1st place in the Case Series/Study Category at the 2019 Symposium on Advanced Wound Care Fall.

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