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Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (CMN/ELA)
This study has been completed.
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
Fundación Diógenes
Information provided by:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT00855400
First received: March 3, 2009
Last updated: December 1, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis | Procedure: Laminectomy and bone marrow stem cells transplantation Procedure: Autologous bone marrow cells collection | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
Further study details as provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Primary Outcome Measures:
- Forced vital capacity [ Time Frame: Every 3 months ]
Secondary Outcome Measures:
- ALS-FRS, MRC and Norris scales [ Time Frame: Every 3 months ]
- Absence of adverse events [ Time Frame: Every week / month depending on the study phase ]
| Enrollment: | 11 |
| Study Start Date: | February 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transplant
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
|
Procedure: Laminectomy and bone marrow stem cells transplantation
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Procedure: Autologous bone marrow cells collection
Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnose established following the World Federation of Neurology criteria
- More than 6 and less than 36 months of evolution of the disease
- Medullar onset of the disease
- More than 20 and less than 65 years old
- Forced Vital Capacity equal or superior to 50%
- Total time of oxygen saturation <90% inferior to 2% of the sleeping time
- Signed informed consent
Exclusion Criteria:
- Neurological or psychiatric concomitant disease
- Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
- Concomitant systemic disease
- Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
- Inclusion in other clinical trials
- Unability to understand the informed consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00855400
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855400
Locations
| Spain | |
| Hospital Universitario Virgen de la Arrixaca | |
| El Palmar, Murcia, Spain, 30120 | |
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Hospital General Universitario Morales Meseguer
Fundación Diógenes
Investigators
| Study Director: | Jose Maria Moraleda Jiménez, M.D. Ph.D. | Hospital Universitario Virgen de la Arrixaca |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Javier Júdez Gutiérrez, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| ClinicalTrials.gov Identifier: | NCT00855400 History of Changes |
| Other Study ID Numbers: |
CMN/ELA EudraCT number: 2006-003096-12 ISCIII: EC07/90762 |
| Study First Received: | March 3, 2009 |
| Last Updated: | December 1, 2010 |
Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
|
Amyotrophic Lateral Sclerosis Bone marrow Stem cells Autologous Safety |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on August 18, 2017