Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Royan Institute
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Fever
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Fever
Time Frame: 48hours
Evaluation the rate of fever 48 hours after cell transplantation
Unconsciousness
Time Frame: 48hours
Evaluation the rate of unconsciousness 48hours after cell transplantation.
vomiting
Time Frame: 48hours
Evaluation the rate of vomiting 48hours after cell transplantation.
Secondary Outcomes
- ALS-FRS(6months)
- FVC(6months)
- EMG-NCV(6months)