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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003096-12 | EudraCT Number | ||
| EC07/90762 | Other Identifier | ISCIII |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | 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 assess the feasibility and the security of the intraspinal and intrathecal 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. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous bone marrow stem cells intraspinal transplantation | Experimental | T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation |
|
| Intrathecal infusion of autologous bone marrow stem cells | Experimental | Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells. |
|
| Intrathecal infusion of placebo (saline solution). | Placebo Comparator | Patients were infused 2 ml of saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laminectomy and bone marrow stem cells transplantation | Procedure | Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient. 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 |
|---|---|---|
| Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (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 MarĆa Moraleda JimĆ©nez, M.D. PhD. | Hospital Universitario Virgen de la Arrixaca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | Spain |
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| Label | URL |
|---|---|
| Spanish Cell Therapy Network | View source |
| Amyotrophic Lateral Sclerosis | View source |
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| DiĆ³genes Foundation |
| OTHER |
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|
| Intrathecal infusion of autologous bone marrow stem cells | Procedure | Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient. Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells. |
|
| Intrathecal infusion of placebo (saline solution). | Procedure | Patients were infused 2 ml of saline solution |
|
| Neurophysiological variables: Electromyography, polysomnography, evoked potentials | Every 3 months |
| Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI) | Every 3 months |
| Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry. | Every 3 months |
| Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS) | Every 3 months |
| 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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