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

NCT ID: NCT00282646

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Arterial Occlusive Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intraarterial administration of BM-MNC or placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

intraarterial application of bone marrow mononuclear cells

Group Type ACTIVE_COMPARATOR

intraarterial stem cell therapy

Intervention Type PROCEDURE

catheter delivery of stem cells

Stem cells

Intervention Type OTHER

intraarterial application of bone marrow mononuclear cells versus placebo

2

intraarterial application of placebo

Group Type PLACEBO_COMPARATOR

intraarterial stem cell therapy

Intervention Type PROCEDURE

catheter delivery of stem cells

Stem cells

Intervention Type OTHER

intraarterial application of bone marrow mononuclear cells versus placebo

Interventions

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intraarterial stem cell therapy

catheter delivery of stem cells

Intervention Type PROCEDURE

Stem cells

intraarterial application of bone marrow mononuclear cells versus placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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A. M. Zeiher

Prof. Dr. A.M. Zeiher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas M Zeiher, MD

Role: PRINCIPAL_INVESTIGATOR

Div. of Cardiology, University of Frankfurt, Germany

Dirk H Walter, MD

Role: STUDY_DIRECTOR

Div. of Cardiology, University of Frankfurt, Germany

Locations

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Div. of Cardiology and Vascular Medicine

Frankfurt, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.

Reference Type DERIVED
PMID: 21586692 (View on PubMed)

Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter 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. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4.

Reference Type DERIVED
PMID: 21205939 (View on PubMed)

Other Identifiers

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PROVASA

Identifier Type: -

Identifier Source: secondary_id

2005-000968-33

Identifier Type: -

Identifier Source: org_study_id