A Phase 2 interventional study of Ixmyelocel-T and Placebo in Peripheral Arterial Disease, sponsored by Vericel Corporation. Completed at 20 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Vericel Corporation · Phase 2, Interventional, and Treatment
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 86 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Vericel Corporation is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment arm of the study will receive injections of the study cellular product.
Biological: Ixmyelocel-T
The control arm of the study will receive placebo injections.
Biological: Placebo
IM injection
IM Injection
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
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Vericel Corporation