Stem cell therapy in ALS

Phase 2

Recruiting

• Conditions: G12.21; Amyotrophic lateral sclerosis.; Amyotrophic lateral sclerosis

• Registration Number: IRCT20160809029275N2
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with ALS approved by neurologist with 31-46 ALSFRS-R score
Patients should be treated with a fixed dose of Rilozule 3 months ago.
Patients should not be detrimental to any other chronic disease and do not use ventilator.

Exclusion Criteria

Patients with malignancy
Patients with other chronic disruptive diseases
Pregnancy
Others Neurodegenerative disease

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FVC measurement. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Spirometery test.;Evaluation of TCD4 + CD25 + lymphocyte cells. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Flowcytometery technique.;Earned score based on ALS-FRS test. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Standard Questionnaire.;Evaluation of serum levels of cytokines, IL-1 ß, TNF-a, IL-10, IFN-?. Timepoint: Before, 1 and 3 months after injection of mesenchymal stem cells. Method of measurement: Using Elisa method.