NCT02383654

Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis

An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: Male
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Autologous Adipose-Tissue Derived Stem Cells	1. Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells 2. Patient will receive brain implantation of approximately 100 -400million 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 .

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-03-09
• Last updated: 2016-02-01

Locations

1 site across 1 country: Taiwan