Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

March 21, 2006 updated by: University of Naples

Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Naples, Italy, 80134
        • Recruiting
        • University of Naples
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

  • Insuline dependent diabetes
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcome Measures

Outcome Measure
Angiographic and laser doppler measurements after six months from treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Naples

Investigators

  • Study Director: Vincenzo Sica, University of Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

March 22, 2006

Last Update Submitted That Met QC Criteria

March 21, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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