Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by University of Naples.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Naples
ClinicalTrials.gov Identifier:
NCT00306085
First received: March 14, 2006
Last updated: March 21, 2006
Last verified: March 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided by University of Naples

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00306085     History of Changes
Other Study ID Numbers: 1
Study First Received: March 14, 2006
Last Updated: March 21, 2006
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on July 28, 2014