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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
Information provided by:
University of Naples Identifier:
First received: March 14, 2006
Last updated: March 21, 2006
Last verified: March 2006
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

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

Inclusion Criteria:

  • Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

  • Insuline dependent diabetes
  • Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00306085

Contact: Heidi Eisele +39 081/5665685

University of Naples Recruiting
Naples, Italy, 80134
Contact: Maria Carmela Corbisiero    +39081/5665681   
Sponsors and Collaborators
University of Naples
Study Director: Vincenzo Sica University of Naples
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00306085     History of Changes
Other Study ID Numbers: 1
Study First Received: March 14, 2006
Last Updated: March 21, 2006

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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases processed this record on September 25, 2017