Biomarkers evaluation following MSC therapy in ALS patients

Phase 2

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

• Registration Number: IRCT20160809029275N5
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients with ALS confirmed by a neurologist with an ALSFRS-R score between 31-46.
Patients must have been treated with a stable dose of Rilozule for the previous 3 months.
Patients should not have any other chronic diseases and should not use ventilators.
Patients in the age range of 18 to 75 years.

Exclusion Criteria

Patients with malignancy.
Patients with other chronic diseases.
pregnancy.
Suffering from other neurodegenerative diseases.
Simultaneous participation in other clinical trials

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Earned score based on ALS-FRS test. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Standard Questionnaire.;FVC measurement. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using Spirometery test.;Evaluation of serum levels of cytokines, TNFa , MCP-1, NFL, GDNF. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using Elisa method.;Evaluation of MIR 206 , Mir338p, Mir133p expression. Timepoint: Before, 1 and 2 months after injection of mesenchymal stem cells. Method of measurement: Using the Real Time PCR method.