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

January 29, 2016 updated by: Shinn-Zong Lin, China Medical University Hospital

An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Yunlin
      • Beigang, Yunlin, Taiwan
        • China Medical University Beigang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • ADSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline-Day 28-Day 44-Day 60-6 months-9months-12months
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 .
Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
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 .
Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Shinn-Zong Lin, M.D.;PhD., China Medical University Beigand Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 8, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH103-REC2-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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