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Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia

Peripheral Artery Disease Clinical Trial

Official title:
Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty

Clinical Trial Summary

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01351610
Study type Interventional
Source Apceth GmbH & Co. KG
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2011
Completion date October 2015
View Details
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