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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Intrathecal injection of mesenchymal stem cells in patients with ALS
Royan Institute
Tehran, Iran
Fever
Evaluation the rate of fever during 48hour after transplantation
Time frame: 48hours
Unconscious
Evaluation the rate of unconsciousness during 48hour after transplantation
Time frame: 48hours
Vomiting
Evaluation the nausea and vomiting 48hours after transplantation.
Time frame: 48hours
ALS-FRS
Evaluation the improvement of ALS-FRS during 6months after transplantation.
Time frame: 6months
FVC
Evaluation the improvement of FVC by spirometry during 6months after transplantation
Time frame: 6months
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