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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00282646
First received: January 25, 2006
Last updated: August 23, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Ankle brachial index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ulcer size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Walking distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • TCO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282646

Locations
Germany
Div. of Cardiology and Vascular Medicine
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
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

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional 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
Study First Received: January 25, 2006
Last Updated: August 23, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014