NCT00282646

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
PROCEDURE	intraarterial stem cell therapy	catheter delivery of stem cells
OTHER	Stem cells	intraarterial application of bone marrow mononuclear cells versus placebo

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2006-01-27
• Last updated: 2021-10-26

Locations

1 site across 1 country: Germany