Safety and Efficacy of Cell-Free Amniotic Fluid (cfAF) Injections in the Treatment of Chronic, Non-Healing Venous Ulcers: Initial Experience from a Prospective, Multicenter, Phase 2 Study

Introduction: Treatment of chronic non-healing and/or recurrent venous leg ulcers (VLU) represents a significant healthcare problem. Persistent symptomatology despite correction of underlying hemodynamic pathophysiology and standard of care (SOC) treatment of the wound results in a substantial reduction of quality of life and imposes a significant economic burden on society due to increased healthcare costs and decreased productivity. The objective of this study is to assess the safety and efficacy of cell-free amniotic fluid (cfAF) injectables in the treatment of VLUs refractory to SOC treatment.   Methods: Methods. This is a prospective, multicenter, two-part, Phase 2 study (NCT04647240) of patients with non-healing, non-infected, refractory to SOC VLUs (ulcers size 25 cm2) who underwent cfAF treatment. Patients received subcutaneous cfAF injection circumferentially at 3, 6, 9, and 12 o’clock positions, 3 mm outside of the wound margin on weekly (N&#3f3) or biweekly (N&#3f6) interval over a 12-week period. Primary outcomes included complete wound closure, wound area reduction, and pain reduction (defined as change in VAS score from baseline to week 12). Results: Results. Nine males (75%) and 3 females (25%) ranging in age from 41 to 73 years (66.7 ± 9.4 years; mean ± SD) met enrollment eligibility. Nine patients (6 males and 3 females) completed study. At baseline the wound area ranged from 1.6 cm2 to 20.6 cm2 (10.4 ± 6.8 cm2; mean ± SD). Six patients (67%) achieved complete closure by week 12 (5.3 ± 1.5 cfAF injection treatments). The average percent reduction in wound area from baseline was 83.7% ± 30.1. There was a statistically significant change of pain VAS score (-1.89 ± 1.96; p=0.02). Patients tolerated the treatment well without side effects. Discussion: Discussion. Results from our study demonstrate that injectable cfAF treatment is technically feasible, safe and effective in the management of chronic, non-healing VLUs. Data from larger studies are needed to gain additional insights into the safety and efficacy of this novel injectable treatment modality. The on-going placebo-controlled, double blinded randomized controlled clinical trial (Part 2 study) will further characterize cfAF injectable for inclusion as a treatment option for hard-to-heal VLUs that are refractory to SOC treatment. References: