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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-003096-12 | |||
| ISCIII: EC07/90762 |
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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Hospital General Universitario Morales Meseguer | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant | Experimental | T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laminectomy and bone marrow stem cells transplantation | Procedure | T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity | Every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| ALS-FRS, MRC and Norris scales | Every 3 months | |
| Absence of adverse events | Every week / month depending on the study phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Maria Moraleda JimƩnez, M.D. Ph.D. | Hospital Universitario Virgen de la Arrixaca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22415951 | Derived | Blanquer M, Moraleda JM, Iniesta F, Gomez-Espuch J, Meca-Lallana J, Villaverde R, Perez-Espejo MA, Ruiz-Lopez FJ, Garcia Santos JM, Bleda P, Izura V, Saez M, De Mingo P, Vivancos L, Carles R, Jimenez J, Hernandez J, Guardiola J, Del Rio ST, Antunez C, De la Rosa P, Majado MJ, Sanchez-Salinas A, Lopez J, Martinez-Lage JF, Martinez 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. |
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| Diógenes Foundation |
| OTHER |
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| Autologous bone marrow cells collection | Procedure | Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient. |
|
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
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