Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Naples |
---|---|
Information provided by: | University of Naples |
ClinicalTrials.gov Identifier: | NCT00306085 |
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.
Condition | Intervention | Phase |
---|---|---|
Peripheral Vascular Diseases |
Gene Transfer: Autologous bone marrow cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis |
Estimated Enrollment: | 20 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 45 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heidi Eisele | +39 081/5665685 | heidi.eisele@unina2.it |
Italy | |
University of Naples | Recruiting |
Naples, Italy, 80134 | |
Contact: Maria Carmela Corbisiero +39081/5665681 marika_corbi@inwind.it |
Study Director: | Vincenzo Sica | University of Naples |
Study ID Numbers: | 1 |
Study First Received: | March 14, 2006 |
Last Updated: | March 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00306085 History of Changes |
Health Authority: | Italy: Ministry of Health |
Peripheral arterial disease, blood marrow cells, therapeutic angiogenesis. |
Arterial Occlusive Diseases Atherosclerosis Peripheral Vascular Diseases Vascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Atherosclerosis Peripheral Vascular Diseases |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis |