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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02249676
Other study ID # IRB2013-055-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2013
Est. completion date December 31, 2014

Study information

Verified date October 2018
Source Tianjin Medical University General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 objective, the investigators chose efficacy outcomes to assess the Expanded Disability Status (EDSS)态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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 31, 2014
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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:

- 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 Criteria:

- 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

Study Design


Intervention

Biological:
Autologous mesenchymal stem cells
Autologous mesenchymal stem cells

Locations

Country Name City State
China Tianjin Medical University General Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EDSS Compare EDSS change before and one year after mesenchymal stem cells (MSC) infusion change from baseline to one year
Secondary Annual relapse rate Compare annual relapse rate before and one year after MSC infusion 1 year after infusion
Secondary Lesion load Compared lesion load before and one year after MSC infusion 1 year after infusion
Secondary Retinal nerve fiber layer (RNFL) Compared RNFL before and one year after MSC infusion 1 year after infusion
Secondary Cognition Compare cognition questionnaire scale before and one year after MSC infusion 1 year after infusion
Secondary Immunological assessments Compare anti-aquaporin4-ab before and one year after MSC infusion. 1 year after infusion
Secondary Immunological assessments Compare immune cell subpopulation before and one year after MSC infusion. 1 year after infusion
Secondary Immunological assessments Compare cytokine kinetics before and one year after MSC infusion. 1 year after infusion
Secondary cerebral volume Compare cerebral volume before and one year after MSC infusion 1 year after infusion
See also
  Status Clinical Trial Phase
Completed NCT00787722 - Hematopoietic Stem Cell Transplant in Devic's Disease Phase 1/Phase 2
Withdrawn NCT03829566 - Autologous Transplant To End NMO Spectrum Disorder Phase 2/Phase 3
Completed NCT03062579 - A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD Phase 1/Phase 2
Completed NCT00904826 - An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica Phase 1/Phase 2