Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Biological: mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell<br>The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell. | Biological: mesenchymal stem cells<br>* mesenchymal stem cells injection via peripheral vein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fever | The increase of body temperature that is defined as fever, within 72 hours after injection. | 72hours | 
| Unconsciousness | Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score. | 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 
| FVC | Evaluation the improvement of FVC by spirometry, 2 months after cell injection. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose tissue mesenchymal stem cell intravenous injection ALS