Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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Whether the mesenchymal injection on ALS patients is effective or not?

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Detailed Description

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After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cell

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Group Type EXPERIMENTAL

mesenchymal stem cell

Intervention Type BIOLOGICAL

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Interventions

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mesenchymal stem cell

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. sporadic ALS according to escorial criteria
2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
4. normal polysomnography
5. Signed consent form

Exclusion Criteria

1. pregnancy or lactation,
2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
3. Hospitalization due to serious illness in the last two months
4. survival time less than two years
5. Hypersensitivity to any component used in the cell culture

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes