Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
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| ClinicalTrials.gov Identifier: NCT00872326 |
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Recruitment Status :
Completed
First Posted : March 31, 2009
Last Update Posted : November 14, 2014
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Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies
| 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 | 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. | |||||||||
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* 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 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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