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

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Procedure: Autologous Adipose-Tissue Derived Stem Cells

• Registration Number: NCT02383654
• Lead Sponsor: China Medical University Hospital

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 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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compassionate Treatment	Autologous Adipose-Tissue Derived Stem Cells	ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation.

Primary Outcome Measures

Name	Time	Method
changes of ALS-FRS score	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	Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths	check the changes of respiratory functions after intervention .
changes of neurologic function	Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths	check any changes of neurologic functions after intervention .

Secondary Outcome Measures

Name	Time	Method
changes of brain structure	Baseline-Day 60- 6 mounths-12 mounths	check changes of MRI after intervention

Trial Locations

Locations (1)

China Medical University Beigang Hospital; 🇨🇳 Beigang, Yunlin, Taiwan