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Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

NCT00306085 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2006-03-22

No results posted yet for this study

Summary

Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:\>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.

Conditions

  • Peripheral Vascular Diseases

Interventions

GENETIC

Autologous bone marrow cells

Sponsors & Collaborators

  • University of Naples

    lead OTHER

Principal Investigators

  • Vincenzo Sica · University of Naples

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-04-30
Completion
2006-04-30

Countries

  • Italy

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 NCT00306085 on ClinicalTrials.gov