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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01364246

Enrollment

Registered

2011-06-02

Start date

2010-01-31

Completion date

2014-12-31

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica., Progressive Multiple Sclerosis

Keywords

Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell

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.

Interventions

BIOLOGICALhuman umbilical cord mesenchymal stem cells

Participants will be given hUC-MSCs transplantation.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Score of Expanded Disability Status Scale (EDSS)	1 year after treatment

Secondary

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

Countries

China

Contacts

Primary ContactYun Yun Xu

xuyun20042001@yahoo.com.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026