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NCT00306085 Clinical Trial

Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

Peripheral Vascular Diseases Clinical Trial

Official title:
Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00306085
Other study ID # 1
Secondary ID
Status Recruiting
Phase Phase 1
First received March 14, 2006
Last updated March 21, 2006
Start date April 2005
Est. completion date April 2006

Study information
Verified date March 2006
Source University of Naples
Contact Heidi Eisele
Phone +39 081/5665685
Email heidi.eisele@unina2.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 90 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

- Insuline dependent diabetes

- Cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• Autologous bone marrow cells

Locations
Country Name City State
Italy University of Naples Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
Secondary Angiographic and laser doppler measurements after six months from treatment.
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