Investigating the simultaneous effect of nanocurcumin and autologous mesenchymal stem cells in ALS patients
Phase 1
- Conditions
- Amyotrophic lateral sclerosis.Amyotrophic lateral sclerosisG12.21
- Registration Number
- IRCT20160809029275N4
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Definite Amyotrophic Lateral Sclerosis ( ALS) patients who have been diagnosed with ALS by a specialist neurologist and have The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale-R (ALSFRS-R) of 31 to 46
Patients who have been treated with a define dose of Rilozule for the past three months.
Patients who have entered the study by filling the informed consent form.
Patients who do not use ventilators
Patients who do not have any other chronic diseases that may interfere with the study.
Exclusion Criteria
The presence of specific autoimmune and underlying diseases, cancer and any malignancy.
Simultaneous participation in other clinical trials.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale ( ALSFRS-R). Timepoint: Before the study and 6 months after the intervention. Method of measurement: Using an international standard questionnaire.;Determination of Forced vital capacity (FVC). Timepoint: Before the study and 6 months after the intervention. Method of measurement: Using a spirometry test.
- Secondary Outcome Measures
Name Time Method Measurement of IL-10, TGF-? and IL-4 cytokines. Timepoint: Before the study and 6 months after the intervention. Method of measurement: Elisa test.