The products have previously been applied, under Aifa (Italian Medicines Agency) authorization, to over 1,500 patients in different Italian hospitals without a single adverse case. The collected data showed significant clinical efficacy in terms of rapid and pronounced improvement in the wound bed with significant improvement in all scores (injury bed, wound appearance, wound exudation) at day 40 from the start of treatment in terms of:
· Wound size reduction
· High response rate
· High healing rate
Excellent safety and tolerability (no adverse cases)
CLINICAL TRIALS 2025-26
A two-part study, Phase I with dose escalation, to evaluate the safety and tolerability of three different doses of allogeneic fibroblasts for the treatment of chronic refractory wounds and, Phase II, to identify the best dose for cohort expansion to evaluate efficacy and confirm safety and tolerability. Study population:
Phase I, a total of 12males and females, aged 18 to 80 years, with chronic refractory wounds (2 cohorts of 6 subjects each).
Phase II, the population will study 40 males and females, aged between 18 and 80 years, with chronic refractory wounds.
Duration of the study: Phase I is scheduled to last 26 weeks. If no serious side effects are observed within 4 weeks after the end of Phase I, Phase II will start and end after 36 weeks.