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

(Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282646

Enrollment

Registered

2006-01-27

Start date

2005-10-31

Completion date

2011-03-31

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases

Keywords

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

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

Interventions

PROCEDUREintraarterial stem cell therapy

catheter delivery of stem cells

OTHERStem cells

intraarterial application of bone marrow mononuclear cells versus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Intraarterial administration of BM-MNC or placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ankle brachial index	6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026