Effects of cell therapy and exosome in the treatment of amyotrophic lateral sclerosis
- Conditions
- Amyotrophic lateral sclerosisG12.21Amyotrophic Lateral Sclerosis.
- Registration Number
- IRCT20200904048610N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 5
Definitive diagnosis of ALS (according to laboratory findings or El Escorial criteria)
Duration of symptoms less than 36 months
Progressive muscle weakness in the lower limb, based on EMG in the lower limb bilaterally
Mandatory vital capacity more than 60% of the predicted normal in lying on the back
Age 18 and above
Ability to provide informed consent
The person can be geographically available and refer for the required visits.
Being accompanied by a caregiver and performing the care needed by him during the study
Failure to use riluzole or a fixed dose in the previous 30 days or more
In women of reproductive age, having a negative pregnancy test before stem cell injection
Medically able to perform thoracolumbar laminectomy or laminoplasty as determined by the surgeon.
Medically able to tolerate an immunosuppressive regimen.
Use of aggressive breathing equipment
Diagnosis of other significant or unstable medical and clinical conditions that can interfere with the study.
The occurrence of any of the following situations: Alcohol consumption with illegal and non-prescription drugs, Appearance of known immunodeficiency syndrome, Unstable medical conditions, Occurrence of unstable psychiatric diseases including psychosis, or major depression
People of reproductive age who are not interested in birth control.
Receiving any other investigational device or drug
Any condition in the lower limb that prevents the testing of muscle strength
Any condition that the specialist feels can cause difficulty in performing injections and follow-ups
Any condition or subset of ALS that the researcher feels could interfere with the study or final interpretation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Score in revised ALS functional rating scale (ALSFRS-R). Timepoint: 1, 3 and 6 months and 1 year. Method of measurement: revised ALS functional rating scale (ALSFRS-R).;The patient's score is Forced Vital Capacity (FVC). Timepoint: 1, 3 and 6 months and 1 year. Method of measurement: Spirometry.
- Secondary Outcome Measures
Name Time Method