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

Primary Purpose

Progressive Multiple Sclerosis, Neuromyelitis Optica.

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
Sponsored by
Shenzhen Beike Bio-Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Multiple Sclerosis focused on measuring Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing University Medical College Affiliated Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human umbilical cord mesenchymal stem cells transplantation

Arm Description

Intervention group

Outcomes

Primary Outcome Measures

Score of Expanded Disability Status Scale (EDSS)

Secondary Outcome Measures

Visual Evoked Potential (VEP)
Brainstem Auditory Evoked Potential (BAEP)
Somatosensory Evoked Potential(SEP)
Brain Magnetic Resonance Imaging （MRI） Scan

Full Information

First Posted
May 31, 2011
Last Updated
November 26, 2012
Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Nanjing Brain Hospital of Nanjing University Medical School, Nanjing University Medical College Affiliated Wuxi Second Hospital, Xuzhou Medical University, The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01364246
Brief Title
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Official Title
Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Nanjing Brain Hospital of Nanjing University Medical School, Nanjing University Medical College Affiliated Wuxi Second Hospital, Xuzhou Medical University, The Second Hospital of Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis, Neuromyelitis Optica.
Keywords
Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Human umbilical cord mesenchymal stem cells transplantation
Arm Type
Experimental
Arm Description
Intervention group
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Description
Participants will be given hUC-MSCs transplantation.
Primary Outcome Measure Information:
Title
Score of Expanded Disability Status Scale (EDSS)
Time Frame
1 year after treatment
Secondary Outcome Measure Information:
Title
Visual Evoked Potential (VEP)
Time Frame
1 year after treatment
Title
Brainstem Auditory Evoked Potential (BAEP)
Time Frame
1 year after treatment
Title
Somatosensory Evoked Potential(SEP)
Time Frame
1 year after treatment
Title
Brain Magnetic Resonance Imaging （MRI） Scan
Time Frame
1 year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Yun Xu
Email
xuyun20042001@yahoo.com.cn
Facility Information:
Facility Name
Nanjing University Medical College Affiliated Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu
Email
xuyun20042001@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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