Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.
the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS\> 24 and (Forced Vital Capacity) FVC\>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
mesenchymal stem cells injection via peripheral vein.
Royan Institute
Tehran, Iran
fever
The increase of body temperature that is defined as fever, within 72 hours after injection.
Time frame: 72hours
Unconsciousness
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
Time frame: 72hours
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
Time frame: 2 months
FVC
Evaluation the improvement of FVC by spirometry, 2 months after cell injection.
Time frame: 2 months
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