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COMPLETED Phase 3

An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

NCT01483898 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 41 participants
Start Date 2012-02
Est. Completion 2014-03-25
Phase Phase 3

Sponsor

Vericel Corporation

5 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vericel Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01483898 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01483898?

The interventions under investigation include: Placebo (OTHER), Ixmyelocel-T (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01483898?

This trial is sponsored by Vericel Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial