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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00282646
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 65
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intraarterial administration of BM-MNC or placeboIntraarterial administration of BM-MNC or placebo
• 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: Oct 1, 2005
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ankle brachial index [6 months]

Secondary Outcome Measures

1. Ulcer size [6 months]

2. Pain [6 months]

3. Walking distance [6 months]

4. TCO2 [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A. M. Zeiher, Prof. Dr. A.M. Zeiher, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT00282646
• Other Study ID Numbers: 2005-000968-33; PROVASA
• First Posted: Jan 27, 2006
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by A. M. Zeiher, Prof. Dr. 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

Study Results

No Results Posted as of Oct 26, 2021