Efficasy and safety of intrathecal injection of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis (ALS)
Phase 2
- Conditions
- Amyotrophic lateral sclerosis.Amyotrophic lateral sclerosisG12.21
- Registration Number
- IRCT20200828048551N1
- Lead Sponsor
- Ahvaz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Patients diagnosed as definite or probable ALS disease according to EL Escorial criteria
ALSFRS-R more than 26
FVC more than 40%
age 25-70 years
Time passed since onset of the symptoms till inclusion be 3 years or less
Exclusion Criteria
Any major systemic disease
Any coexisting neurodegenerative disease
No other major pathology in brain or spinal cord
pregnancy or lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disability. Timepoint: 3 months. Method of measurement: ALSFRS-R.;Forced vital capacity. Timepoint: 3 months. Method of measurement: spirometry.;Side effects. Timepoint: 3 months. Method of measurement: Questionnaire.
- Secondary Outcome Measures
Name Time Method