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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02383654

Enrollment

Registered

2015-03-09

Start date

2015-01-31

Completion date

2016-01-31

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, 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 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

Interventions

PROCEDUREAutologous 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 .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 50 Years

Healthy volunteers

Inclusion criteria

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
changes of brain structure	Baseline-Day 60- 6 mounths-12 mounths	check changes of MRI after intervention

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026