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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383654
• Other study ID #: CMUH103-REC2-072
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2015
• Last updated: January 29, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare, Dept. of medical affairs
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Procedure:
• Autologous Adipose-Tissue Derived Stem Cells
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 .

Locations

Country	Name	City	State
Taiwan	China Medical University Beigang Hospital	Beigang	Yunlin

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	changes of respiratory function	check the changes of respiratory functions after intervention .	Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths	Yes
Primary	changes of neurologic function	check any changes of neurologic functions after intervention .	Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths	Yes
Secondary	changes of brain structure	check changes of MRI after intervention	Baseline-Day 60- 6 mounths-12 mounths	Yes