Amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis
Conditions
Interventions
Intervention group: Patients with sporadic amyotrophic lateral sclerosis receive an allogeneic adipose tissue mesenchymal stem cell suspension with a concentration of 2 million cells in 10 ml of norma
Sponsors
Royan Institute
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age: 18-65 Both gender Duration of disease onset: 6 months Both type of ALS: Limb onset & Bulbar onset FVC =40% ALS-FRS= 23 Under treatment with Rilozule
Exclusion criteria
Exclusion criteria: Neurological and psychiatric concomitant disease Concomitant systemic disease Treatment with corticosteroid ,Ig,immunosuppressive during 12 months Familial ALS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects include systolic pressure greater than 180 mm Hg or less than 90 mm Hg, or more than 30 mm Hg change from baseline, diastolic pressure greater than 100 mm Hg or less than 50 mm Hg, or more than 30 mm Hg change from baseline, heart rate more than 110 or more than 33% increase, or heart rate less than 60 or less than 33% decrease, oxygen saturation (grade 2 according to CTACAE version 4.0) , Temperature more than 38 or more than 1 degree increase, any toxic side effects according to CTACAE version 4.0, itching, urticaria, erythema, edema, headache, restlessness, nausea, vomiting, decreased level of meningitis, encephalitis, formation Mass, the formation of abnormal tissue in the nervous system or other parts of the body, worsening of the disease. Timepoint: One day, two months, four months, six months and one year after injection. Method of measurement: Checklist of side effects, blood test, MRI, EMG-NCV and spirometry and The ALS Functional Rating Scale and Amyotrophic Lateral Sclerosis Assessment Questionnaire -ALSAQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression level by measuring The ALS Functional Rating Scale. Timepoint: 2 months, 4 months, 6 months and 12 months after injection of cell suspension. Method of measurement: The ALS Functional Rating Scale.;Disease progression level by Amyotrophic Lateral Sclerosis Assessment Questionnaire. Timepoint: 2 months, 4 months, 6 months and 12 months after injection of cell suspension. Method of measurement: Amyotrophic Lateral Sclerosis Assessment Questionnaire.;Disease progression level by measuring the forced vital capacity. Timepoint: 2 months, 4 months, 6 months and 12 months after injection of cell suspension. Method of measurement: Spirometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNasser Aghdami
Nasser Aghdami
Outcome results
None listed