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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Autologous Adipose-Tissue Derived Stem Cells

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Autologous Adipose-Tissue Derived Stem Cells (ADSCs)

Eligibility Criteria

35 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

China Medical University Beigang Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Compassionate Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

changes of ALS-FRS score

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

changes of respiratory function

check the changes of respiratory functions after intervention .

changes of neurologic function

check any changes of neurologic functions after intervention .

Secondary Outcome Measures

changes of brain structure

check changes of MRI after intervention

Full Information

NCT ID

NCT02383654

First Posted

February 8, 2015

Last Updated

January 29, 2016

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02383654

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, Autologous Adipose-Tissue Derived Stem Cells (ADSCs)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Compassionate Treatment

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Autologous Adipose-Tissue Derived Stem Cells

Other Intervention Name(s)

ADSCs

Intervention Description

Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells 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 .

Primary Outcome Measure Information:

Title

changes of ALS-FRS score

Description

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

Time Frame

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

Title

changes of respiratory function

Description

check the changes of respiratory functions after intervention .

Time Frame

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

Title

changes of neurologic function

Description

check any changes of neurologic functions after intervention .

Time Frame

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

Secondary Outcome Measure Information:

Title

changes of brain structure

Description

check changes of MRI after intervention

Time Frame

Baseline-Day 60- 6 mounths-12 mounths

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shinn-Zong Lin, M.D.;PhD.

Organizational Affiliation

China Medical University Beigand Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

China Medical University Beigang Hospital

City

Beigang

State/Province

Yunlin

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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