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

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: Progressive Multiple Sclerosis; Neuromyelitis Optica.
• Intervention / Treatment: Biological: human umbilical cord mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yun Yun Xu; Email: xuyun20042001@yahoo.com.cn

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• 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

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: Progressive Multiple Sclerosis; neuromyelitis optica; Umbilical Cord Mesenchymal Stem Cell
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Neuromyelitis Optica
• Other Study ID Numbers: BKCR-MS-1.0(2010)