Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)

October 18, 2021 updated by: A. M. Zeiher, Johann Wolfgang Goethe University Hospital

(Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)

Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main goal:

Improvement of limb perfusion (Ankle brachial index).

Secondary aims:

Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Div. of Cardiology and Vascular Medicine

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with PAOD (Stage III or IV)
  • Distal arterial occlusions
  • Patients with Buergers Disease
  • Signed informed consent

Exclusion Criteria:

  • Successful bypass operation or intervention within the last 3 months
  • Active infection, feber, chronic inflammatory disease
  • HIV, Hepatitis
  • Tumor within the last 5 years, complete remission required
  • Stroke or myocardial infarction within last 3 months
  • Renal insufficiency (creatinine > 2 mg/dl)
  • Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5).
  • Anemia (hemoglobin < <10 mg/dl)
  • Thrombocytopenia < 100.000/µl
  • Allergies to Aspirin, Clopidogrel, Heparin
  • Bleeding disorder
  • Gastrointestinal bleeding within last 3 months
  • Surgery or trauma within the last 2 months
  • Pregnancy
  • Mental retardation
  • Inclusion in other clinical study within last 30 days

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
intraarterial application of bone marrow mononuclear cells
Procedure: intraarterial stem cell therapy
catheter delivery of stem cells
Other: Stem cells
intraarterial application of bone marrow mononuclear cells versus placebo
Placebo Comparator: 2
intraarterial application of placebo
Procedure: intraarterial stem cell therapy
catheter delivery of stem cells
Other: Stem cells
intraarterial application of bone marrow mononuclear cells versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ankle brachial index
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 6 months
6 months
Ulcer size
Time Frame: 6 months
6 months
Walking distance
Time Frame: 6 months
6 months
TCO2
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Andreas M Zeiher, MD, Div. of Cardiology, University of Frankfurt, Germany
  • Study Director: Dirk H Walter, MD, Div. of Cardiology, University of Frankfurt, Germany

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

October 1, 2005

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 25, 2006

First Submitted That Met QC Criteria

January 25, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-000968-33
  • PROVASA

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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