Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

University of Naples

Status and phase: Unknown; Phase 1

Conditions: Peripheral Vascular Diseases

Treatments: Genetic: Autologous bone marrow cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00306085

1

Details and patient eligibility

About

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.

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion criteria

• Insuline dependent diabetes
• Cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind