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Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)

NCT00498069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-03-19

No results posted yet for this study

Summary

Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis

Conditions

  • Ischemia

Interventions

DEVICE

Harvest Smartprep2 BMAC System

injection of 40cc bmac

DEVICE

SmartPReP2 BMAC System

Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System

BIOLOGICAL

placebo

injection of placebo into ischemic tissue of the lower extremity

Sponsors & Collaborators

  • Harvest Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT00498069 on ClinicalTrials.gov