Clinical trial NCT00282646: Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Official title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arterial Occlusive Diseases
Keywords: critical limb ischemia
peripheral arterial occlusive disease
[C14.907.137]
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2006-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intraarterial administration of BM-MNC or placebo
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Ankle brachial index
timeFrame: 6 months
Secondary outcomes:
measure: Ulcer size
timeFrame: 6 months
measure: Pain
timeFrame: 6 months
measure: Walking distance
timeFrame: 6 months
measure: TCO2
timeFrame: 6 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Div. of Cardiology and Vascular Medicine
Study officials:
affiliation: Div. of Cardiology, University of Frankfurt, Germany
name: Andreas M Zeiher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Div. of Cardiology, University of Frankfurt, Germany
name: Dirk H Walter, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.