MedDataX Logo

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

NCT ID: NCT01364246

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Progressive Multiple Sclerosis Neuromyelitis Optica.

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Progressive Multiple Sclerosis neuromyelitis optica Umbilical Cord Mesenchymal Stem Cell

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Human umbilical cord mesenchymal stem cells transplantation

Intervention group

Group Type EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Participants will be given hUC-MSCs transplantation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

human umbilical cord mesenchymal stem cells

Participants will be given hUC-MSCs transplantation.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Nanjing University Medical College Affiliated Wuxi Second Hospital

UNKNOWN

Sponsor Role collaborator

Xuzhou Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanjing University Medical College Affiliated Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yun Yun Xu

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yun Xu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BKCR-MS-1.0(2010)

Identifier Type: -

Identifier Source: org_study_id