A Bilayered Living Cellular Construct Accelerates the Rate of Wound Healing in Venous Leg Ulcers

Purpose:  To characterize differences in the rate of venous leg ulcer (VLU) wound healing between conventional therapy and a bilayered living cellular construct (BLCC). 

Methods: The safety and effectiveness of BLCC vs. conventional therapy was evaluated in 240 VLUs in a randomized, controlled clinical trial (N=130 BLCC; N=110 conventional therapy).  Subjects were eligible for up to 5 BLCC administrations within the first 3 weeks.  Wound area was calculated from wound tracings taken at each visit.  Wound healing was evaluated through 6 months of follow-up.

Results:  The mean wound area at baseline was 11.9 cm² (N=238 VLUs).  During the period of active administration of BLCC, BLCC-treated wounds showed an immediate and sustained reduction in mean wound size from baseline vs. conventional therapy (Week 1: 27% vs. 10%; Week 2: 32% vs. 20%; Week 3: 35% vs. 27%; Week 4: 39% vs. 29%).  A Cox proportional hazards model showed that BLCC-treated VLUs had a 28% faster time to complete wound closure through 6 months compared with conventional therapy (likelihood ratio p-value=0.0223). Adverse events attributable to treatment were similar between groups.

Conclusion: The results demonstrated an early acceleration of wound area reduction during the initial 4 weeks for BLCC compared with conventional therapy, coinciding with the active application of BLCC.  This early acceleration led to faster complete wound closure in BLCC-treated wounds. The data suggest that the speed at which a wound can be reduced in size may be further optimized with BLCC.  This suggests a ‘healing momentum’ following BLCC application that leads to an accelerated trajectory toward closure.