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NCT Number: NCT02383654

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

35 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

China Medical University Beigang Hospital

Beigang, Yunlin, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Autologous Adipose-Tissue Derived Stem Cells

Procedure
  • 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 .

Other names: ADSCs

Primary outcomes

  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 outcomes

  1. changes of brain structure

    Time frame: Baseline-Day 60- 6 mounths-12 mounths

    check changes of MRI after intervention

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2015
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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