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Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

NCT01049919 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-05-28

Study results available
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Summary

This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease

Interventions

DEVICE

Bone marrow concentration device

Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb

PROCEDURE

Placebo procedure (sham)

Sham bone marrow aspiration, sham delivery to affected limb

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Michael P. Murphy, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-06-30
Completion
2020-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT01049919 on ClinicalTrials.gov