Trial | NCT01759797  Report issue

Title

Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    stem cells ...

  • Study Participants

    6
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 Started
Jan 31
2013
Primary Completion
Jan 31
2014
Study Completion
Mar 31
2014
Last Update
Jul 06
2016
Estimate

Biological intra venous injection of stem cell

Intra venous injection of mesenchymal stem cell

  • Other names: Stem cell transplantation

stem cell reciepient Experimental

the patients with ALS who underwent intravenous injection of mesenchymal stem cell.

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.
No Results Posted