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Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

NCT00468000 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease

Interventions

BIOLOGICAL

Ixmyelocel-T

IM injection

BIOLOGICAL

Placebo

IM Injection

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Anthony J Comerota, MD · Jobst Vascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468000 on ClinicalTrials.gov