Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With PAOD

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, November 2007

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00282646

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	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ]

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
Estimated Study Completion Date:	October 2008

Intervention Details:

catheter delivery of stem cells

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

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

Contacts

Contact: Dirk H Walter, MD

+49 69 6301 ext 5932

d.walter@em.uni-frankfurt.de

Locations

Germany
Div. of Cardiology and Vascular Medicine	Recruiting
Frankfurt, Germany, 60590
Contact: Dirk H Walter, MD +49 69 6301 ext 5932 d.walter@em.uni-frankfurt.de
Contact: Andreas M Zeiher, MD +49 69 6301 ext 5789 zeiher@em.uni-frankfurt.de
Principal Investigator: Andreas M Zeiher, MD

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

Study ID Numbers:	2005-000968-33, PROVASA
Study First Received:	January 25, 2006
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00282646
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:

peripheral arterial occlusive disease, (III and IV Fontaine)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases
Neovascularization, Pathologic

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009