NCT00306085
Unknown
Phase 1
Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
University of Naples1 site in 1 country20 target enrollmentApril 2005
ConditionsPeripheral Vascular Diseases
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.
Investigators
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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