Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Biological: intra venous injection of stem cell

• Registration Number: NCT01759797
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-12-31
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Last Update Submitted: 2016-07-02
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell reciepient	intra venous injection of stem cell	the patients with ALS who underwent intravenous injection of mesenchymal stem cell.

Primary Outcome Measures

Name	Time	Method
Fever	48hours	Evaluation the rate of fever 48 hours after cell transplantation
Unconsciousness	48hours	Evaluation the rate of unconsciousness 48hours after cell transplantation.
vomiting	48hours	Evaluation the rate of vomiting 48hours after cell transplantation.

Secondary Outcome Measures

Name	Time	Method
ALS-FRS	6months	Evaluation the improvement of ALS-FRS during 6months after cell transplantation.
FVC	6months	Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.
EMG-NCV	6months	Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of