Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal S

Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

CompletedPhase 1Phase 2MS (type not specified)NCT02034188

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Umbilical cord mesenchymal stem cells

What it measured

Main measures

  • Number of participants with adverse events

    12 months

    Safety

Other measures (8)

  • Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)

    12 months

    Disability progression

  • Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale

    12 months

  • Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)

    12 months

    Thinking and memory

  • Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test

    12 months

    Arm and hand function

  • Number of participants with a change in mobility and leg function as measured by the 25 foot walking test

    12 months

    Walking and mobility

  • Number of participants with a change in quality of life as measured by the Short form 36 (SF-36) quality of life questionnaire

    12 months

    Quality of life (reported by participants)

  • Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)

    1 month, 3 months

  • Number of participants with a change in brain or spinal cord lesions as measured by gadolinium-enhanced magnetic resonance imaging (MRI)

    12 months

    MRI lesions

Who could take part

MS (type not specified) · 18 to 55 · EDSS 0 to 5

Show the full criteria

Inclusion criteria

* Patients willing to sign informed consent and capable of understanding the features of this clinical trial. * Willing to keep a weekly diary and undergo observation for 12 months * Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Poser criteria for clinically defined MS. * EDSS scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of MS. * Must have proof of health insurance in country of residence.

Exclusion criteria

* Patients with evidence of active proliferative retinopathy. * Patients with poorly controlled diabetes mellitus (glycated hemoglobin: HbA1C > 8.5%). * Patients with renal insufficiency (Creatinine> 2.5) or failure. * Infection as evidenced by white blood cell (WBC) count of >15,000 k/cumm and/or temperature > 38 Celsius. * History of organ transplant. * History of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix * Exercise limiting angina ( Canadian Cardiovascular Society Class 3 * Congestive heart failure (New York Heart Association class 3 * Unstable angina * Acute ST elevation myocardial infarction (MI) within 1month * Transient ischemic heart attack or stroke within 1 month * Severe valvular heart disease

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

About this trial

In the sponsor's words

Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.

Papers

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Related trials

History

    1. Started

      Jan 2014

    2. Main results due

      Mar 2016

    3. Finished

      Mar 2016

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