NCT02383654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

February 8, 2015

Last Update Submit

January 29, 2016

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisAutologous Adipose-Tissue Derived Stem Cells (ADSCs)

Outcome Measures

Primary Outcomes (3)

  • changes of ALS-FRS score

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

    Baseline-Day 28-Day 44-Day 60-6 months-9months-12months

  • changes of respiratory function

    check the changes of respiratory functions after intervention .

    Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths

  • changes of neurologic function

    check any changes of neurologic functions after intervention .

    Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths

Secondary Outcomes (1)

  • changes of brain structure

    Baseline-Day 60- 6 mounths-12 mounths

Study Arms (1)

Compassionate Treatment

OTHER

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

Procedure: Autologous Adipose-Tissue Derived Stem Cells

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 .

Also known as: ADSCs
Compassionate Treatment

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

China Medical University Beigang Hospital

Beigang, Yunlin, Taiwan

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shinn-Zong Lin, M.D.;PhD.

    China Medical University Beigand Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Superintendent, China Medical University Beigang Hospital, Taiwan

Study Record Dates

First Submitted

February 8, 2015

First Posted

March 9, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

TW(1)