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
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | March 30, 2009 | |||||||||
First Posted Date ICMJE | March 31, 2009 | |||||||||
Last Update Posted Date | November 14, 2014 | |||||||||
Study Start Date ICMJE | December 2007 | |||||||||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ] | |||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
Ankle-Brachial pressure index [ Time Frame: 3 months ] | |||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia | |||||||||
Official Title ICMJE | Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia | |||||||||
Brief 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:
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | Experimental: Autologous Bone Marrow Mononuclear Cells
Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
Intervention: Procedure: Autologous Bone Marrow Mononuclear Cells
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Publications * | Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Pérez-Camacho I, Marcos-Sánchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
20 | |||||||||
Original Actual Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | May 2009 | |||||||||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Spain | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00872326 | |||||||||
Other Study ID Numbers ICMJE | C/ICPD/2007 FPS C/ICPD/2007 |
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Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Andalusian Network for Design and Translation of Advanced Therapies | |||||||||
Study Sponsor ICMJE | Andalusian Network for Design and Translation of Advanced Therapies | |||||||||
Collaborators ICMJE | Carlos III Health Institute | |||||||||
Investigators ICMJE |
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PRS Account | Andalusian Network for Design and Translation of Advanced Therapies | |||||||||
Verification Date | November 2014 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |