NCT01364246

Brief Summary

Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis. Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

3.2 years

First QC Date

May 31, 2011

Last Update Submit

November 26, 2012

Conditions

Progressive Multiple SclerosisNeuromyelitis Optica.

Keywords

Progressive Multiple Sclerosisneuromyelitis opticaUmbilical Cord Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (1)

  • Score of Expanded Disability Status Scale (EDSS)

    1 year after treatment

Secondary Outcomes (4)

  • Visual Evoked Potential (VEP)

    1 year after treatment

  • Brainstem Auditory Evoked Potential (BAEP)

    1 year after treatment

  • Somatosensory Evoked Potential(SEP)

    1 year after treatment

  • Brain Magnetic Resonance Imaging （MRI） Scan

    1 year after treatment

Study Arms (1)

Human umbilical cord mesenchymal stem cells transplantation

EXPERIMENTAL

Intervention group

Biological: human umbilical cord mesenchymal stem cells

Interventions

human umbilical cord mesenchymal stem cellsBIOLOGICAL

Participants will be given hUC-MSCs transplantation.

Human umbilical cord mesenchymal stem cells transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.
  • Aged 16-65 years.
  • Disease duration≥2years
  • Poor response to steroid therapy.
  • Written informed consent and follow the clinic trail procedure

You may not qualify if:

  • Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.
  • Combined Pneumonia or other Severe systemic bacteria infection.
  • Severe drug allergic history or anaphylaxis to 2 or more food or medicine.
  • Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/
  • HIV+, TPPA +， patients diagnosed as HBV or HCV.
  • Tumor Markers +
  • Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form.
  • Coagulation disorders.
  • Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg.
  • Pregnancy.
  • Enrollment in other trials in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing University Medical College Affiliated Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic ProgressiveNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Central Study Contacts

Yun Yun Xu

CONTACT

xuyun20042001@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2013

Study Completion

December 1, 2014

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

CN(1)