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

C

China Medical University

Status and phase

Completed
Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Procedure: Autologous Adipose-Tissue Derived Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02383654
CMUH103-REC2-072

Details and patient eligibility

About

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.

Full 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

Enrollment

1 patient

Sex

Male

Ages

35 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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