Amyotrophic lateral sclerosis (ALS). Amyotrophic lateral sclerosis
Conditions
Interventions
Intervention groups: Intravenous or intrathecal injection of 60 millions of Wharton’s jelly derived mesenchymal stromal cells in two doses/ 3 months- WJMSCs are suspended in 10 ml N/S for intravenous
Sponsors
Celltech Pharmed Co.
Royan Stem Cell Technology Co.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age: 18-70 Both gender Disease onset at least: 6 months All patients diagnosed with ALS and R/O of differential diagnosis FVC =40% ALSFRS-R= 25 Under treatment with rilozule and edaravone Ability to walk even with aid and ability to tolerate the procedures
Exclusion criteria
Exclusion criteria: Concomitant psychiatric or cognitive disease Concomitant systemic disease (uncontrolled HTN, uncontrolled DM, uncontrolled kidney diseases, HF, …) Treatment with corticosteroid , IVIg, immunosuppressive and cytotoxic during 12 months Dependency to ventilation History of malignancy Concomitant other neurodegenerative disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: Evaluation of possible side effects at intervals of 24 hours, 1 month, 3 months, 6 and 12 months after injection. Method of measurement: side effects questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ALSFRS-R score. Timepoint: 1, 3, 6 and 12 months after transplantation. Method of measurement: ALSFRS-R questionnaire.;Changes in FVC percent (spirometery). Timepoint: 6 and 12 months after transplantation. Method of measurement: Spirometry.;One-year survival. Timepoint: one year. Method of measurement: visiting the patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Madani
Royan Research Institute
Outcome results
None listed