Peripheral Vascular Diseases
Conditions
Keywords
Peripheral arterial disease,, blood marrow cells,, therapeutic angiogenesis.
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.
Interventions
GENETICAutologous bone marrow cells
Sponsors
University of Naples
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of third or fourth class of peripheral atherosclerosis
Exclusion criteria
* Insuline dependent diabetes * Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic and laser doppler measurements after six months from treatment. | — |
Countries
Italy
Contacts
Primary ContactHeidi Eisele
Outcome results
None listed