Amyotrophic Lateral Sclerosis. Amyotrophic lateral sclerosis
Conditions
Interventions
Intervention 1: Intervention group: They receive MSCs derived from bone marrow. Intervention 2: Intervention group: They receive exosomes. Intervention 3: Intervention group: They receive bone marrow-
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSajad Sahab Negah
Mashhad University of Medical Sciences
Outcome results
None listed