Status:
COMPLETED
Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Devic's Syndrome
Devic's Neuromyelitis Optica
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 objectiv...
Eligibility Criteria
Inclusion
- 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:
- Increase of 1 EDSS point (if baseline EDSS\<5.0) or 0.5 EDSS points (if baseline EDSS \>5.5)
- Moderate-severe relapses in past 18 months
- Gadolinium enhancing lesions (double or triple dose Gd)
- 1 new T2 lesion
- Evidence of recent inflammatory disease, as evidenced by any one of the following:
- 1 moderate-severe relapses in past 18 months
- 1 Gd-enhancing lesions (single, double or triple dose Gd)
- 1 new T2 lesion
Exclusion
- Received Immune inhibitors immunomodulator during the three months before the trial
- Significant cardiac, renal, or hepatic failure or any other disease that may affect the results of the study
- Allergies
- Pregnant or possibly pregnant
- Cognitive decline to understand or sign the informed consent
- Brain tumor, HIV (+) tumor marker (+), blood pressure (BP): 200 /110 mmHg
- Judged not suitable by doctors
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02249676
Start Date
January 1 2013
End Date
December 31 2014
Last Update
October 17 2018
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052