NCT02551679

ACP-01 in Patients With Critical Limb Ischemia

A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Hemostemix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.

Detailed description

This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options. A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site. The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks. One futility analysis for potentially stopping study enrollment will be performed. Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving. The control group will receive placebo injections into the lower extremity to ensure blinding of the assessors and the subjects. The placebo will consist of the same medium used in the ACP product suspension. The study consists of four periods: Screening period, Treatment period, Acute safety follow-up and Long term follow-up periods. The total duration of study participation, including follow-up, is at least 26 weeks. Subjects will be followed for up to 52 weeks and at least until the last subject has completed his/her 26 week visit.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	ACP-01	Injection into lower extremity
BIOLOGICAL	Placebo	Injection into lower extremity

Timeline

• Start date: 2014-08-01
• Primary completion: 2020-04-01
• Completion: 2021-04-01
• First posted: 2015-09-16
• Last updated: 2023-11-28
• Results posted: 2023-11-18

Locations

19 sites across 2 countries: United States, Canada