The effect of Granolocyte Colony Stimulating Factor in treatment of Amyotrophic Lateral Sclerosis
Not Applicable
- Conditions
- amyotrophic lateral sclerosis.Diseases of the nervous system
- Registration Number
- IRCT201207238509N2
- Lead Sponsor
- Iranian neurology research center of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
inclusion criteria: age between 18 and 85, definite or probable ALS according to revised El Escorial criteria, maximum 2 years from initiation of symptoms to study entry, mild to moderate disability according to ALSFRS-r , permanent use of rilosole for at least 30 days.
exclusion criteria: familial ALS, pregnancy or lactation, neoplasia, mieloproliferative or hematologic disorders, active immunological disease, splenomegaly, liver or renal or heart disease, HIV positive, FVC below 50%, significant cognitive disorder, hypersensitivity to GCSF
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient`s function. Timepoint: before intervention and 3 months after intervention. Method of measurement: ALS functional rating scale questioner.
- Secondary Outcome Measures
Name Time Method Mobilizing bone marrow stem cells. Timepoint: before intervention and day 3 and 6 after initiation of intervention. Method of measurement: CD34 count.;Amplitude of compound muscle action potential in ulnar and proneal nerve. Timepoint: before intervention and3 months after initiation of intervention. Method of measurement: EMG-NCV.;Quality of life. Timepoint: before intervention and 3 months after intervention. Method of measurement: ALSAQ-40 questioner.;Muscle power. Timepoint: before intervention and 3 months after intervention. Method of measurement: Manual muscle test.