Amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis
Conditions
Interventions
Intervention group: In the single study arm for evaluating the safety of the study intervention, patients will initially undergo the placement of an Ommaya reservoir. After that, first cell injection
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Definite ALS according to the revised El Escorial criteria Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) score between 31 and 46 Disease duration no longer than 5 years after the onset of the first symptom Riluzole treatment for at least 3 months
Exclusion criteria
Exclusion criteria: Forced vital capacity (FVC) of <40% of the predicted value Tracheostomy Coagulopathy Any psychiatric disorders Hepatic, renal, hematologic, or active pulmonary disorders Current or previous history of malignancy CNS infection (e.g., abscess) immunosuppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity. Timepoint: At 1-, 2- and 3-month after the injection. Method of measurement: Monitoring and evaluating the patients regarding the adverse events based on Common Terminology Criteria for Adverse Events (CTCAE). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). Timepoint: 3, 6, and 12 months after the first injection. Method of measurement: Evaluation and physical examination of the patient.;Forced vital capacity (FVC). Timepoint: 3, 6, and 12 months after the first injection. Method of measurement: Spirometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed Oraee Yazdani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed