Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Study 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.

Official Title
-----------------
Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Biological: intrathecal injection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cell reciepient<br>The patients with ALS that underwent mesenchymal stem cell transplantation | Biological: intrathecal injection<br>* Intrathecal injection of mesenchymal stem cells in patients with ALS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever | Evaluation the rate of fever during 48hour after transplantation | 48hours | 
| Unconscious | Evaluation the rate of unconsciousness during 48hour after transplantation | 48hours | 
| Vomiting | Evaluation the nausea and vomiting 48hours after transplantation. | 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALS-FRS | Evaluation the improvement of ALS-FRS during 6months after transplantation. | 6months | 
| FVC | Evaluation the improvement of FVC by spirometry during 6months after transplantation | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS intrathecal injection bone marrow mesenchymal stem cell