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Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI

NCT00595257 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-03-09

No results posted yet for this study

Summary

The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.

Conditions

  • Arterial Occlusive Diseases

Interventions

DEVICE

centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)

autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs

Sponsors & Collaborators

  • Harvest Technologies

    lead INDUSTRY

Principal Investigators

  • R E Arasan, MD · LifeCell India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-10-31
Completion
2010-04-30

Countries

  • India

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 NCT00595257 on ClinicalTrials.gov