Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title: A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia

Status Suspended

Clinical Trial Summary

A randomized, double-blind placebo controlled study to determine the safety and efficacy of Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients treated with standard of care and with no surgical revascularization option. It is assumed that the ACP-treated group will have a lower amputation and death rate as compared to the placebo group. Other hemodynamic, imaging and clinical parameters will also be compared between the two groups. Quality of life assessments will also be performed.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

• NCT number: NCT02140931
• Study type: Interventional
• Source: Hemostemix
• Status: Suspended
• Phase: Phase 2
• Start date: August 2014
• Completion date: July 2022