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

China Medical University Hospital1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Autologous Adipose-Tissue Derived Stem CellsPROCEDURE

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 .

Eligibility

Sex: MALEMin age: 35 YearsMax age: 50 Years

Medical Language ↔ Plain English

Compassionate Treatment The number of participants for a person. The patients (Guo XX) of 28% of lung function assessment (normal lung function was greater than 80%), the daily life of motor function score was 17 points (normal function score of 40 points).

Locations (1)

China Medical University Beigang Hospital

Beigang, Yunlin, Taiwan

Outcomes

Primary Outcomes

changes of ALS-FRS score

using ALS-FRS score to assess patient's function after transplantation.

Time frame: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months

changes of respiratory function

check the changes of respiratory functions after intervention .

Time frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths

changes of neurologic function

check any changes of neurologic functions after intervention .

Time frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths

Secondary Outcomes

changes of brain structure

check changes of MRI after intervention

Time frame: Baseline-Day 60- 6 mounths-12 mounths

Data from ClinicalTrials.gov

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