Trial | NCT02116634  Report issue

Title

Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis
Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
Whether the mesenchymal injection on ALS patients is effective or not?
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.
Study Started
May 31
2015
Primary Completion
May 31
2017
Anticipated
Study Completion
May 31
2017
Anticipated
Last Update
Jan 14
2016
Estimate

Biological mesenchymal stem cell

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

mesenchymal stem cell Experimental

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

Criteria 

Inclusion Criteria:

sporadic ALS according to escorial criteria
onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
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
normal polysomnography
Signed consent form

Exclusion Criteria:

pregnancy or lactation,
vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
Hospitalization due to serious illness in the last two months
survival time less than two years
Hypersensitivity to any component used in the cell culture
No Results Posted