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

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)

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

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

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):

Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. Epub 2011 May 17.

Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schlüter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. Epub 2011 Jan 4.

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 May 23, 2013