Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (CMN/ELA)
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ClinicalTrials.gov Identifier: NCT00855400 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Last Update Posted : December 2, 2010
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Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators:
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Hospital General Universitario Morales Meseguer
Diógenes Foundation
Information provided by:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Tracking Information | ||||
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First Submitted Date ICMJE | March 3, 2009 | |||
First Posted Date ICMJE | March 4, 2009 | |||
Last Update Posted Date | December 2, 2010 | |||
Study Start Date ICMJE | February 2007 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Forced vital capacity [ Time Frame: Every 3 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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 | Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis | |||
Official Title ICMJE | Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis | |||
Brief Summary | The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients. | |||
Detailed Description | Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Amyotrophic Lateral Sclerosis | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Transplant
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Interventions:
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Publications * | Blanquer M, Moraleda JM, Iniesta F, Gómez-Espuch J, Meca-Lallana J, Villaverde R, Pérez-Espejo MÁ, Ruíz-López FJ, García Santos JM, Bleda P, Izura V, Sáez M, De Mingo P, Vivancos L, Carles R, Jiménez J, Hernández J, Guardiola J, Del Rio ST, Antúnez C, De la Rosa P, Majado MJ, Sánchez-Salinas A, López J, Martínez-Lage JF, Martínez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080. | |||
* 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 |
11 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2010 | |||
Actual Primary Completion Date | October 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 | 20 Years to 65 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 | NCT00855400 | |||
Other Study ID Numbers ICMJE | CMN/ELA EudraCT number: 2006-003096-12 ISCIII: EC07/90762 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Javier Júdez Gutiérrez, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | |||
Study Sponsor ICMJE | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | |||
Verification Date | December 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |