Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|