Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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