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The stereotaxis can be threatful for the patients because of respiratory insufficiency
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ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.
In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell recipient | Experimental | The patients who underwent mesenchymal stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraventricular injection | Biological | intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS |
|
| Measure | Description | Time Frame |
|---|---|---|
| fever | evaluation the rate of fever 48hours after stem cell injection | 48hours |
| unconsciousness | evaluation the rate of unconsciousness during 6months after stem cell injection. | 6months |
| brain hematoma | Evaluation the rate of hematoma 48hours after stem cell injection. | 48hours |
| vomiting | evaluation the rate of vomiting 48hours after stem cell injection. | 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| ALS-FRS | evaluation the improvement of ALS-FRS 6months after stem cell injection. | 6months |
| EMG-NCV | evaluation the improvement of EMG-NCV after stem cell injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of Royan department of degenerative medicine,Head of Royan celltherapy center | Study Director |
| Ali Reza Zali, MD | Head of Neurosurgery research center of Shahid Beheshti University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
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| ID | Term |
|---|---|
| D007276 | Injections, Intraventricular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 6months |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |