NCT01351610

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Apceth GmbH & Co. KG · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Critical Limb Ischemia
• Peripheral Artery Disease

Interventions

Type	Name	Description
BIOLOGICAL	PTA + Infusion of MSC_Apceth	percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth
PROCEDURE	PTA	percutaneous transluminal angioplasty only

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2011-05-11
• Last updated: 2015-12-15

Locations

1 site across 1 country: Germany