Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Royan Institute

Status and phase: Completed; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Biological: intrathecal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01771640

Royan-Nerve-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

stem cell reciepient

Experimental group

Description:

The patients with ALS that underwent mesenchymal stem cell transplantation

Treatment:

Biological: intrathecal injection