An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) (REVIVE)
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|ClinicalTrials.gov Identifier: NCT01483898|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Biological: Ixmyelocel-T Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Ixmyelocel-T In Subjects With Critical Limb Ischemia And No Options For Revascularization|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.
|Placebo Comparator: Placebo||
On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.
- Amputation free survival (AFS) at 12 months post-injection [ Time Frame: 12 months ]The primary objective will be to assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on AFS at 12 months post-injection in CLI patients with no options for revascularization. Amputation free survival is defined as time to the first occurrence of either major amputation (above the talus) in the index leg or all-cause mortality (death).
- Percent of patients with adverse events [ Time Frame: 18 months ]A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with CLI from time of aspiration through 18 months post-treatment/follow-up by % of patients with adverse events.
- Percent of patients with complete wound closure by Month 12 [ Time Frame: 12 months ]A secondary objective is to assess the percent of patients with at least 1 ischemic wound on the index leg that is present at Visit 3 (preinjection) having complete closure by Month 12.
- Percent of patients experiencing a major cardiac event (MACE) by Months 6, 12, and 18 [ Time Frame: 6, 12 and 18 months ]% of patients experiencing a MACE event defined as cardiovascular mortality, myocardial infarction, chest pain requiring hospitalization, or stroke.
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): NCT01483898
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