Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis
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|ClinicalTrials.gov Identifier: NCT02383654|
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Procedure: Autologous Adipose-Tissue Derived Stem Cells||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation.
Procedure: Autologous Adipose-Tissue Derived Stem Cells
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 .
Other Name: ADSCs
- changes of ALS-FRS score [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months ]using ALS-FRS score to assess patient's function after transplantation.
- changes of respiratory function [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths ]check the changes of respiratory functions after intervention .
- changes of neurologic function [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths ]check any changes of neurologic functions after intervention .
- changes of brain structure [ Time Frame: Baseline-Day 60- 6 mounths-12 mounths ]check changes of MRI after intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383654
|China Medical University Beigang Hospital|
|Beigang, Yunlin, Taiwan|
|Principal Investigator:||Shinn-Zong Lin, M.D.;PhD.||China Medical University Beigand Hospital, Taiwan|