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NCT01483898 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
A Phase 3 study of Critical Limb Ischemia, sponsored by Vericel Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT01483898: Completed Phase 3 study of Critical Limb Ischemia, sponsored by Vericel Corporation.
NCT01483898 is a Phase 3 study of Critical Limb Ischemia that has completed, run by Vericel Corporation. The registered enrollment target is 41 participants, below the 89-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01483898, a Phase 3 study of Critical Limb Ischemia, has completed, sponsored by Vericel Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI patients who have no option for revascularization procedures. All patients randomized will undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control into their pre-identified index leg. Patients will be followed for 18 months.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Ixmyelocel-T
Study Locations (20)
California
- John Muir Medical Center - Concord Campus - Concord
- VA Loma Linda Healthcare - Loma Linda
- UCLA Gonda Venous Center & Ambulatory Procedure Unit - Los Angeles
- Sutter Medical Group - Cardiology - Sacramento
- University of California San Diego Medical Center - San Diego
- Kaiser Permanente Medical Center - San Diego
- University of California San Francisco - Division of Vascular and Endovascular Surgery - San Francisco
Alabama
- Cardiology PC - Birmingham
- Cardio-Thoracic Surgeons, P.C. - Birmingham
- University Of Alabama At Birmingham - Birmingham
Arizona
- Arizona Heart Institute - Phoenix
- Carl T. Hayden VA Medical Center - Phoenix
- University of Arizona - Tucson
Florida
- Bethesda Memorial Hospital - Clinical Research Center - Boynton Beach
- Holy Cross Hospital - Fort Lauderdale
- Florida Research Network, LLC - Gainesville
Arkansas
- Arkansas Primary Care Clinic, P.A. - Little Rock
- Central Arkansas Veteran's Healthcare System - Little Rock
Colorado
- University of Colorado Denver - Anschutz Medical Campus - Aurora
Connecticut
- Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-03-25 |
| Phase | Phase 3 |
What the finished NCT01483898 record still lists
NCT01483898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 89-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01483898 names 20 study sites across 7 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01483898 about?
NCT01483898 is a clinical study titled "An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)". This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI patients who have no option for revascul...
What is the current status of trial NCT01483898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2012-02. Estimated completion is 2014-03-25.
What conditions does trial NCT01483898 study?
This clinical trial studies the following conditions: Critical Limb Ischemia.
What interventions are being tested in trial NCT01483898?
The interventions under investigation include: Placebo (OTHER), Ixmyelocel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01483898?
This trial is sponsored by Vericel Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01483898 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01483898's enrollment target sits among peer trials
41 10th of 18 higher than 9 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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