Efficacy and safety of intraspinal injection of neural stem cell on progression of amyotrophic lateral sclerosis (ALS)
Phase 2
- Conditions
- Amyotrophic lateral sclerosis.Motor neuron disease
- Registration Number
- IRCT201107221696N3
- Lead Sponsor
- Shafa Neuroscience Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Inclusion Criteria:
1. Definite, probable or laboratory supported probable ALS (El Escorial criteria)
2. age 25-70 yrs
3. disease progression for duration of more than 6 months and less than 36 months
4. EMG-NCV confirms the diagnosis
5. FVC more than 50%
6. INR less than 1.5
7. Platelet count more than 100000
Exclusion criteria:
1. Any major systemic or psychiatric illness
2. any coexisting neurodegenerative disease
3. No other major pathology in brain or spinal cord
4. history of hematologic or lymphoproliferative disease
5. history of stem cell treatment of any kind
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disability. Timepoint: Six months. Method of measurement: ALSFRS-R.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: Six months. Method of measurement: ALSAQ40.;Forced vital capacity. Timepoint: Six months. Method of measurement: Spirometry.;Electrophysiologic parameters. Timepoint: Six months. Method of measurement: EMG-NCV.;Muscle strength. Timepoint: Six months. Method of measurement: MRC.;Side effects. Timepoint: Six months. Method of measurement: Questionnaire.