Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
|Peripheral Vascular Diseases Diabetic Foot||Procedure: Autologous Bone Marrow Mononuclear Cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia|
- Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ]
- Ankle-Brachial pressure index [ Time Frame: 3 months ]
|Study Start Date:||December 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Autologous Bone Marrow Mononuclear Cells
Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872326
|University Hospital Virgen Macarena|
|Seville, Spain, 41007|
|Principal Investigator:||Antonio de la Cuesta, MD||Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro|
|Principal Investigator:||Manuel Constantino, PhD||Chief of Hematology. Hospital Universitario Virgen Macarena|
|Principal Investigator:||Rafael J Ruiz-Salmeron, PhD||Chief of Endovascular Unit. Hospital Universitario Virgen Macarena|