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

Arterial Occlusive Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282646
• Other study ID #: 2005-000968-33
• Secondary ID: PROVASA
• Status: Completed
• Phase: Phase 2
• Start date: October 2005
• Est. completion date: March 2011

Study information

• Verified date: October 2021
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease

Intervention

Procedure:
• intraarterial stem cell therapy
catheter delivery of stem cells

Other:
• Stem cells
intraarterial application of bone marrow mononuclear cells versus placebo

Locations

Country	Name	City	State
Germany	Div. of Cardiology and Vascular Medicine	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle brachial index		6 months
Secondary	Ulcer size		6 months
Secondary	Pain		6 months
Secondary	Walking distance		6 months
Secondary	TCO2		6 months