Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT00872326|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : November 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases Diabetic Foot||Procedure: Autologous Bone Marrow Mononuclear Cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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.
- Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ]
- Ankle-Brachial pressure index [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|