Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease

June 23, 2005 updated by: Murphy, Michael P., MD

Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia

The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. For patients with limb threatening ischemia the only option for relief of rest pain or gangrene is amputation.

There is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. In this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. The procedure will require about 4 hours and the subjects will be admitted to the Indiana University Medical Center overnight. The follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing.

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 Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Sub-Investigator:
          • Keith L March, MD,PhD

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

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe peripheral vascular disease not amenable to bypass or angioplasty
  • Age >21 years old
  • Normal renal function (creatinine < 1.6)

Exclusion Criteria:

  • Congestive heart failure (ejection fraction [EF]<30%)
  • History of cancer or myeloproliferative disorders
  • Proliferative retinopathy
  • Pregnancy
  • Cognitively disabled

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events recorded in the 12 week study period
Serious Adverse events recorded for one year

Secondary Outcome Measures

Outcome Measure
Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing

Collaborators and Investigators

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

Sponsor

Murphy, Michael P., MD

Collaborators

Indiana University School of Medicine

Investigators

  • Principal Investigator: Michael P Murphy, MD, Indiana University School of Medicine

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

Helpful Links

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

December 1, 2004

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

June 6, 2005

First Submitted That Met QC Criteria

June 6, 2005

First Posted (ESTIMATE)

June 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUPUI 0503-14

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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