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

January 25, 2006
August 23, 2011
October 2005
October 2010   (final data collection date for primary outcome measure)
Ankle brachial index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Ankle brachial index
Complete list of historical versions of study NCT00282646 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Ulcer size
  • Pain
  • Walking distance
  • TCO2
Not Provided
Not Provided
 
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
(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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arterial Occlusive Diseases
  • Procedure: intraarterial stem cell therapy
    catheter delivery of stem cells
  • Other: Stem cells
    intraarterial application of bone marrow mononuclear cells versus placebo
  • Active Comparator: 1
    intraarterial application of bone marrow mononuclear cells
    Interventions:
    • Procedure: intraarterial stem cell therapy
    • Other: Stem cells
  • Placebo Comparator: 2
    intraarterial application of placebo
    Interventions:
    • Procedure: intraarterial stem cell therapy
    • Other: Stem cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00282646
2005-000968-33, PROVASA
No
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
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
Johann Wolfgang Goethe University Hospitals
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP