NCT00872326

Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia

Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.

Detailed description

Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease. After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes. Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of: * Changes in below-the-knee angiography from baseline to 3 months follow-up. * Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.

Conditions

• Peripheral Vascular Diseases
• Diabetic Foot

Interventions

Type	Name	Description
PROCEDURE	Autologous Bone Marrow Mononuclear Cells	Infusion \> 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2009-03-31
• Last updated: 2014-11-14

Locations

1 site across 1 country: Spain