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Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central nervous system affecting vision and brain and spinal cord function which leads to accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No agent has been found to be highly effective in halting disease activity.Based on recent outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including multiple sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators anticipate that mesenchymal stem cells transplantation may provide lasting disease stability for neuromyelitis optica patients.
Primary objective was to assess feasibility and safety; the investigators compared adverse events from up to 3months before treatment until up to 12 months after the infusion.
As a secondary objective, the investigators chose efficacy outcomes to assess the Expanded Disability Status (EDSS)、annual relapse rate (ARR) and time to next relapse after transplant.
Third objective anterior visual pathway and pyramidal tract as a model of wider disease. Masked endpoint analyses was used for electrophysiological and selected imaging outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous mesenchymal stem cells group | Experimental | Generated clinical-grade MSC 10 mg chlorpheniramine Po.;100 mg hydrocortisone iv.;10 mg metoclopramide im.;30 min before administration of the cells . MSC a day-case 2·0×106 cells/kg i.v. 15min Infused normal saline 500 Ml over 4 h i.v. |
|
| Control group | Placebo Comparator | Patients with progressive and refractory NMO treated with regular methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Biological | Autologous mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| EDSS | Compare EDSS change before and one year after mesenchymal stem cells (MSC) infusion | change from baseline to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Annual relapse rate | Compare annual relapse rate before and one year after MSC infusion | 1 year after infusion |
| Lesion load | Compared lesion load before and one year after MSC infusion |
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Inclusion Criteria:
Clinically definite neuromyelitis optica or neuromyelitis optica spectrum disorder
Age > 18 year
EDSS > 3
Progression continued relapses or worsening MRI after at least a year of attempted therapy as evidenced by one or more of the following:
Evidence of recent inflammatory disease, as evidenced by any one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fu-Dong Shi, MD,PhD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| 1 year after infusion |
| Retinal nerve fiber layer (RNFL) | Compared RNFL before and one year after MSC infusion | 1 year after infusion |
| Cognition | Compare cognition questionnaire scale before and one year after MSC infusion | 1 year after infusion |
| Immunological assessments | Compare anti-aquaporin4-ab before and one year after MSC infusion. | 1 year after infusion |
| Immunological assessments | Compare immune cell subpopulation before and one year after MSC infusion. | 1 year after infusion |
| Immunological assessments | Compare cytokine kinetics before and one year after MSC infusion. | 1 year after infusion |
| cerebral volume | Compare cerebral volume before and one year after MSC infusion | 1 year after infusion |
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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