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Clinical Trials/NCT00306085
NCT00306085
Unknown
Phase 1

Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

University of Naples1 site in 1 country20 target enrollmentApril 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Peripheral Vascular Diseases
Sponsor
University of Naples
Enrollment
20
Locations
1
Primary Endpoint
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
Last Updated
20 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
April 2006
Last Updated
20 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Naples

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria

  • Insuline dependent diabetes

Outcomes

Primary Outcomes

Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcomes

  • Angiographic and laser doppler measurements after six months from treatment.

Study Sites (1)

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