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The purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.
This pilot clinical trial is design to see the safety and possible efficiency of ADSCs treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3 months, 6 months 9 months and 12 months.
Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety before and after brain implantation.
Timing of Study: 12months recruitment period after approvals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compassionate Treatment | Other | ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose-Tissue Derived Stem Cells | Procedure |
Patient will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice , before brain implantation, and will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice, after brain implantation . |
| Measure | Description | Time Frame |
|---|---|---|
| changes of ALS-FRS score | using ALS-FRS score to assess patient's function after transplantation. | Baseline-Day 28-Day 44-Day 60-6 months-9months-12months |
| changes of respiratory function | check the changes of respiratory functions after intervention . | Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths |
| changes of neurologic function | check any changes of neurologic functions after intervention . | Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths |
| Measure | Description | Time Frame |
|---|---|---|
| changes of brain structure | check changes of MRI after intervention | Baseline-Day 60- 6 mounths-12 mounths |
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Compassionate Treatment
The number of participants for a person.
The patients (Guo XX) of 28% of lung function assessment (normal lung function was greater than 80%), the daily life of motor function score was 17 points (normal function score of 40 points).
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| Name | Affiliation | Role |
|---|---|---|
| Shinn-Zong Lin, M.D.;PhD. | China Medical University Beigand Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Beigang Hospital | Beigang | Yunlin | Taiwan |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |