Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03668353 - Recombinant SeV-hFGF2/dF Injection for PAOD Phase 1
Recruiting NCT04110964 - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT Phase 1
Not yet recruiting NCT03994666 - Cell Therapy in Critical Limb Ischemia Phase 2
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Not yet recruiting NCT02498080 - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia N/A
Recruiting NCT02239419 - Evaluation of Carbothera in the Treatment of Foot Ulcers N/A
Recruiting NCT01938872 - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia N/A
Active, not recruiting NCT01211925 - Distal Venous Arterialisation of Ischemic Limb Phase 2/Phase 3
Completed NCT02454231 - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Phase 2/Phase 3
Completed NCT01758874 - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Phase 2
Completed NCT02475200 - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting NCT04583436 - Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia N/A
Completed NCT04071782 - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore N/A
Completed NCT03669458 - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. N/A
Not yet recruiting NCT06007469 - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting NCT04110327 - An All-Comers Observational Study of the MicroStentâ„¢ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed NCT02260622 - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia Phase 2
Recruiting NCT02054416 - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality N/A