A spray-based therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts, HP802-247, is associated with a reduction in the wound area of chronic venous leg ulcers, according to a phase 2 study published online Aug. 3 in The Lancet.
Robert S. Kirsner, M.D., from the University of Miami Miller School of Medicine, and colleagues examined the benefit and harm of HP802-247 at different concentrations and dosing frequencies in adult outpatients with chronic venous leg ulcers. Participants, with at least one ulcer measuring 2 to 12 cm² in area that had persisted for six to 104 weeks, were randomized to receive 5.0 × 106 cells per mL every seven days (45 patients) or every 14 days (44 patients); 0.5 × 106 cells per mL every seven days (43 patients) or every 14 days (46 patients); or vehicle alone every seven days (50 patients). All groups received compression bandages.
The researchers found that 205 patients completed all required visits. Compared with vehicle, active treatment correlated with significantly greater mean reduction in wound area (P = 0.0446), with the greatest improvement seen with a dose of 0.5 × 106 cells per mL every 14 days (15.98 percent; P = 0.0028). Across all groups, the adverse events were similar, with only cellulitis and new skin ulcers occurring in more than 5 percent of patients.
"In this trial, several dosing regimens seemed to provide benefit to patients compared with vehicle," the authors write. "The results are sufficiently promising that larger randomized trials comparing HP802-247 to standard treatment for venous leg ulcers are now warranted."
Several authors disclosed financial ties to Healthpoint Biotherapeutics, which funded the study.
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