Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Royan Institute
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- fever
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both gender
- •Age: 18-55
- •Sporadic form of disease
- •ALS-FRS\> = 24
- •FVC \>= 40%
Exclusion Criteria
- •Familial form of ALS
- •Malignancy
- •Autoimmune disease
- •Diagnosis of other motor neuron diseases
Outcomes
Primary Outcomes
fever
Time Frame: 72hours
The increase of body temperature that is defined as fever, within 72 hours after injection.
Unconsciousness
Time Frame: 72hours
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
Secondary Outcomes
- The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)(2 months)
- FVC(2 months)