CompletedNCT00282646Updated Oct 26, 2021

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

A Phase 2 interventional study of intraarterial stem cell therapy and Stem cells in Arterial Occlusive Diseases, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Johann Wolfgang Goethe University Hospital · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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

Conditions studied

Arterial Occlusive Diseases

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Keywords

critical limb ischemia
peripheral arterial occlusive disease
[C14.907.137]

In context

Arterial Occlusive Diseases

296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.

This study's enrollment of 40 is below the median of 121 across 200 interventional studies indexed under Arterial Occlusive Diseases.

Browse Arterial Occlusive Diseases studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: 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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (actual)

Study arms

Active comparator
1
intraarterial application of bone marrow mononuclear cells
Procedure: intraarterial stem cell therapy · Other: Stem cells
Placebo comparator
2
intraarterial application of placebo
Procedure: intraarterial stem cell therapy · Other: Stem cells

Interventions

Procedureintraarterial stem cell therapy
catheter delivery of stem cells
OtherStem cells
intraarterial application of bone marrow mononuclear cells versus placebo

What researchers measure

Primary outcomes

Ankle brachial index
Time frame: 6 months

Secondary outcomes

Ulcer size
Time frame: 6 months
Pain
Time frame: 6 months
Walking distance
Time frame: 6 months
TCO2
Time frame: 6 months

Study locations

1 site

Div. of Cardiology and Vascular Medicine
Frankfurt, 60590, Germany

References and documents

Publications

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. PubMed 21586692 ↗
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. PubMed 21205939 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00282646
Lead sponsor: Johann Wolfgang Goethe University Hospital
Responsible party: A. M. Zeiher (Prof. Dr. A.M. Zeiher, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted: Jan 27, 2006
Start date: Oct 2005
Primary completion: Oct 2010
Completion: Mar 2011
Last update: Oct 26, 2021

Study contacts

Andreas M Zeiher, MD

principal investigator · Div. of Cardiology, University of Frankfurt, Germany

Dirk H Walter, MD

study director · Div. of Cardiology, University of Frankfurt, Germany

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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