Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia (RESTORE-CLI)
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|ClinicalTrials.gov Identifier: NCT00468000|
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 20, 2020
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.
The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Biological: Ixmyelocel-T Biological: Placebo||Phase 2|
The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.
Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.
The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
The treatment arm of the study will receive injections of the study cellular product.
Placebo Comparator: Placebo
The control arm of the study will receive placebo injections.
- Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale) [ Time Frame: throughout trial ]
- Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene) [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]
- Percentage of patients failing treatment [ Time Frame: Day 7, and Months 3,6,9, and 12 ]
- Time to major amputation [ Time Frame: Day 7 and Month 3, 6, 9, and 12 ]
- Percentage of patients undergoing major amputation [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]
- Incidence of revascularization interventions throughout duration of study [ Time Frame: Day 7 and Months 3,6,9,12 ]
- Incidence of bypass surgery for patients throughout duration of study [ Time Frame: Day 7 and Months 3,6,9,12 ]
- Healing of all wounds in the target limb [ Time Frame: Day 7 and Months 3,6,9,12 ]
- Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index [ Time Frame: Day 7 and Months 3,6,9,12 ]
- Pain, as measured by visual analog scale(VAS) [ Time Frame: Day 7 and Months 3,6,9,12 ]
- The King's College Vascular Quality of Life Questionnaire [ Time Frame: Baseline and Months 6 and 12 ]
- Walking distance as measured by six-minute walk test(with or without walking device) [ Time Frame: Baseline and Month 12 ]
- Concurrent Meds for trends [ Time Frame: Day 7 and Months 3, 6, 9, 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468000
|Principal Investigator:||Anthony J Comerota, MD||Jobst Vascular Center|