Critical Limb Ischemia (CLI)
We recently started enrolling patients with CLI in our phase II trial of ACP-01.
The clinical trial is a prospective, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ACP-01.
Eligibility: Patients with CLI (Rutherford Category IV and V) who meet other inclusion criteria.
Control: Two-thirds of enrolled patients will receive ACP-01; one-third will receive placebo.
Endpoints: Primary endpoints are (a) decrease in the rate of treatment failure as defined by major amputation/mortality rate, and (b) decrease from baseline to 3 and 6 months in chronic ulcer size and severity. Additional secondary endpoints will also be assessed. They include clinical and quantitative parameters that can support the efficacy of the therapy in comparison to the existing standard of care.
DSMB: The Company is in the process of constituting an independent Data Safety Monitoring Board (DSMB). The DSMB will conduct formal and independent safety evaluations in compliance with and as scheduled in the trial design.