Amyotrophic Lateral Sclerosis
Conditions
Keywords
ALS intrathecal injection bone marrow mesenchymal stem cell
Brief summary
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.
Detailed description
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.
Interventions
Intrathecal injection of mesenchymal stem cells in patients with ALS
Sponsors
Study design
Eligibility
Inclusion criteria
* Age:18-65 * both gender * duration of disease\<2 years * FVC\>40% ALS-FRS\>26
Exclusion criteria
* neurological and psychiatric concomitant disease * concomitant systemic disease * treatment with corticosteroid,Ig,immunosuppressive during 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fever | 48hours | Evaluation the rate of fever during 48hour after transplantation |
| Unconscious | 48hours | Evaluation the rate of unconsciousness during 48hour after transplantation |
| Vomiting | 48hours | Evaluation the nausea and vomiting 48hours after transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ALS-FRS | 6months | Evaluation the improvement of ALS-FRS during 6months after transplantation. |
| FVC | 6months | Evaluation the improvement of FVC by spirometry during 6months after transplantation |
Countries
Iran