Status unknownPhase 1Phase 2Progressive MSNCT01364246

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • human umbilical cord mesenchymal stem cells

What it measured

Main measures

  • Score of Expanded Disability Status Scale (EDSS)

    1 year after treatment

    Disability progression

Other measures (4)

  • Visual Evoked Potential (VEP)

    1 year after treatment

    Myelin repair
  • Brainstem Auditory Evoked Potential (BAEP)

    1 year after treatment

    Myelin repair
  • Somatosensory Evoked Potential(SEP)

    1 year after treatment

    Myelin repair
  • Brain Magnetic Resonance Imaging (MRI) Scan

    1 year after treatment

    MRI lesions

Who could take part

Progressive MS · 18 to 60

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jan 2010

      2. Main results due

        Mar 2013

      3. Finished

        Dec 2014

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