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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02383654
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Shinn-Zong Lin, China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Autologous Adipose-Tissue Derived Stem Cells Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Compassionate Treatment
ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation.
 Procedure: Autologous 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 .

Other Name: ADSCs


Outcome Measures
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Primary Outcome Measures :
  1. changes of ALS-FRS score [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months ]
    using ALS-FRS score to assess patient's function after transplantation.

  2. changes of respiratory function [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths ]
    check the changes of respiratory functions after intervention .

  3. changes of neurologic function [ Time Frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths ]
    check any changes of neurologic functions after intervention .


Secondary Outcome Measures :
  1. changes of brain structure [ Time Frame: Baseline-Day 60- 6 mounths-12 mounths ]
    check changes of MRI after intervention


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383654


Locations
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Taiwan
China Medical University Beigang Hospital
Beigang, Yunlin, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Shinn-Zong Lin, M.D.;PhD. China Medical University Beigand Hospital, Taiwan
More Information
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Responsible Party: Shinn-Zong Lin, Superintendent, China Medical University Beigang Hospital, Taiwan, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02383654    
Other Study ID Numbers: CMUH103-REC2-072
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Keywords provided by Shinn-Zong Lin, China Medical University Hospital:
Amyotrophic Lateral Sclerosis
Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
Additional relevant MeSH terms:
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Pathologic Processes
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases