Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

Phase 1

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT00306085
• Lead Sponsor: University of Naples

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Status Verified: 2006-03
• Study First Submitted: 2006-03-14
• Study First Submitted QC: 2006-03-21
• Last Update Submitted: 2006-03-21
• Study First Posted: 2006-03-22
• Last Update Posted: 2006-03-22
• Study Completion: 2006-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria

• Insuline dependent diabetes
• Cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcome Measures

Name	Time	Method
Angiographic and laser doppler measurements after six months from treatment.

Trial Locations

Locations (1)

University of Naples; 🇮🇹 Naples, Italy