Clinical Trial: Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
Brief Summary: 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.
Detailed Summary:
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
Sponsor: China Medical University Hospital
Current Primary Outcome:
- 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 .
Original Primary Outcome:
Current Secondary Outcome: changes of brain structure [ Time Frame: Baseline-Day 60- 6 mounths-12 mounths ]
Original Secondary Outcome:
Information By: China Medical University Hospital
Dates:
Date Received: February 8, 2015
Date Started: January 2015
Date Completion:
Last Updated: January 29, 2016
Last Verified: January 2016