Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell reciepient

The patients with ALS that underwent mesenchymal stem cell transplantation

Group Type EXPERIMENTAL

intrathecal injection

Intervention Type BIOLOGICAL

Intrathecal injection of mesenchymal stem cells in patients with ALS

Interventions

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intrathecal injection

Intrathecal injection of mesenchymal stem cells in patients with ALS

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No