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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282646
First Posted: January 27, 2006
Last Update Posted: August 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
  Purpose
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.

Condition Intervention Phase
Arterial Occlusive Diseases Procedure: intraarterial stem cell therapy Other: Stem cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)

Further study details as provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Ankle brachial index [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Ulcer size [ Time Frame: 6 months ]
  • Pain [ Time Frame: 6 months ]
  • Walking distance [ Time Frame: 6 months ]
  • TCO2 [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: October 2005
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282646


Locations
Germany
Div. of Cardiology and Vascular Medicine
Frankfurt, Germany, 60590
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. M. Zeiher, Prof. Dr. A.M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00282646     History of Changes
Other Study ID Numbers: 2005-000968-33
PROVASA
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: August 24, 2011
Last Verified: March 2011

Keywords provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospitals:
critical limb ischemia
peripheral arterial occlusive disease
[C14.907.137]

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases