Clinical trial NCT01364246: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Progressive Multiple Sclerosis
Neuromyelitis Optica.
Keywords: Progressive Multiple Sclerosis
neuromyelitis optica
Umbilical Cord Mesenchymal Stem Cell
Lead sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Nanjing Medical University
name: Nanjing University Medical College Affiliated Wuxi Second Hospital
name: Xuzhou Medical University
name: The Second Hospital of Nanjing Medical University
First posted: 2011-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Score of Expanded Disability Status Scale (EDSS)
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Visual Evoked Potential (VEP)
timeFrame: 1 year after treatment
measure: Brainstem Auditory Evoked Potential (BAEP)
timeFrame: 1 year after treatment
measure: Somatosensory Evoked Potential(SEP)
timeFrame: 1 year after treatment
measure: Brain Magnetic Resonance Imaging （MRI） Scan
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing University Medical College Affiliated Drum Tower Hospital
state: Jiangsu
Study officials:
References: