Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01483898
The ClinicalTrials.gov registry entry for NCT01483898 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 89-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (54% lower). The listed sponsor is Vericel Corporation, which has 11 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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
Similar trials for Critical Limb Ischemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Trial to Assess Chelation Therapy in Critical Limb Ischemia
RECRUITING · Phase 3
-
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
RECRUITING · Phase 3
-
MOTIV BTK Randomized Controlled Trial
RECRUITING · NA
-
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
RECRUITING · NA
-
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
RECRUITING
-
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.