Amyotrophic Lateral Sclerosis
Conditions
Brief summary
Whether the mesenchymal injection on ALS patients is effective or not?
Detailed description
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
Interventions
BIOLOGICALmesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
Sponsors
Alzahra Hospital, Iran
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. sporadic ALS according to escorial criteria 2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months 3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount 4. normal polysomnography 5. Signed consent form
Exclusion criteria
1. pregnancy or lactation, 2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease 3. Hospitalization due to serious illness in the last two months 4. survival time less than two years 5. Hypersensitivity to any component used in the cell culture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS | every 6 months up 2 years after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| ALS-FRS(functional rating scale) score and EMG scale | before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation |
| FVC (forced vital capacity)and DWSE±QoL score | before transplantation and every 6 months up 2 years after transplantation |
Countries
Iran
Outcome results
None listed