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Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by University of Naples.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306085
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Naples
  Purpose
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 Genetic: Autologous bone marrow cells Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

Resource links provided by NLM:


Further study details as provided by University of Naples:

Primary Outcome Measures:
  • Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcome Measures:
  • Angiographic and laser doppler measurements after six months from treatment.

Estimated Enrollment: 20
Study Start Date: April 2005
Estimated Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

  • Insuline dependent diabetes
  • Cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306085


Contacts
Contact: Heidi Eisele +39 081/5665685 heidi.eisele@unina2.it

Locations
Italy
University of Naples Recruiting
Naples, Italy, 80134
Contact: Maria Carmela Corbisiero    +39081/5665681    marika_corbi@inwind.it   
Sponsors and Collaborators
University of Naples
Investigators
Study Director: Vincenzo Sica University of Naples
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00306085     History of Changes
Other Study ID Numbers: 1
First Submitted: March 14, 2006
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
Last Verified: March 2006

Keywords provided by University of Naples:
Peripheral arterial disease,
blood marrow cells,
therapeutic angiogenesis.

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases