Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

November 26, 2012 updated by: Shenzhen Beike Bio-Technology Co., Ltd.

Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing University Medical College Affiliated Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Other criteria the investigator consider improper for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Intervention group
Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score of Expanded Disability Status Scale (EDSS)
Time Frame: 1 year after treatment
1 year after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Evoked Potential (VEP)
Time Frame: 1 year after treatment
1 year after treatment
Brainstem Auditory Evoked Potential (BAEP)
Time Frame: 1 year after treatment
1 year after treatment
Somatosensory Evoked Potential(SEP)
Time Frame: 1 year after treatment
1 year after treatment
Brain Magnetic Resonance Imaging （MRI） Scan
Time Frame: 1 year after treatment
1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Beike Bio-Technology Co., Ltd.

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Xuzhou Medical University
The Second Hospital of Nanjing Medical University
The Affiliated Nanjing Brain Hospital of Nanjing University Medical School
Nanjing University Medical College Affiliated Wuxi Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKCR-MS-1.0(2010)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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