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

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ClinicalTrials.gov Identifier: NCT00282646
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Arterial Occlusive Diseases Procedure: intraarterial stem cell therapy Other: Stem cells Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
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)
Study Start Date : October 2005
Actual Primary Completion Date : October 2010
Actual Study Completion Date : March 2011

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




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

Secondary Outcome Measures :
  1. Ulcer size [ Time Frame: 6 months ]
  2. Pain [ Time Frame: 6 months ]
  3. Walking distance [ Time Frame: 6 months ]
  4. TCO2 [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

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 Hospital
ClinicalTrials.gov Identifier: NCT00282646     History of Changes
Other Study ID Numbers: 2005-000968-33
PROVASA
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: March 2011

Keywords provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospital:
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