Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
|ClinicalTrials.gov Identifier: NCT02140931|
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2014
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Drug: Injections||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||July 2022|
Active Comparator: Angiogenic Cell Precursors
Intra-muscular injections of Angiogenic Cell Precursors (ACPs) in the ischemic leg
Placebo Comparator: Cell culture medium
Intra-muscular injections of cell culture medium in the ischemic leg
- Time to major amputation / mortality [ Time Frame: 26 weeks ]
- Change from baseline in the level of pain in the treated ischemic leg [ Time Frame: 26 weeks ]
- Change from baseline in the quantity of analgesic drugs used by the patient [ Time Frame: 26 weeks ]
- Change from baseline in ABI (Ankle Brachial Index) [ Time Frame: 26 weeks ]
- Change from baseline in TBI (Toe Brachial Index) [ Time Frame: 26 weeks ]
- Change from baseline in quality of life [ Time Frame: 26 weeks ]
- Change from baseline in ulcer size [ Time Frame: 26 weeks ]
- Total hospitalization time of ACP-treated patients compared to controls [ Time Frame: 26 weeks ]
- Safety of intramuscular injection of ACPs [ Time Frame: 26 weeks ]
- Vital signs
- Physical examination
- Clinical laboratory values
- Adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140931
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1K3|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Study Director:||Christy Pifer, BS||Hemostemix, Inc.|