Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Memory Loss
Treatment
Allogeneic umbilical cord mesenchymal stem cells
Control group
Clinical Study ID
Ages 20-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients are willing to sign informed consent.
Male or female are age between 20 to 65 years old on date of consent.
Diagnosis of Relapsing-Remitting MS (RRMS) (≥1 clinically documented relapse in thepast 12 months, ≥2 clinically documented relapses in the last 24 months or ≥ 1gadolinium enhanced lesion or T2 new lesion in the last 12 months) or SecondaryProgressive MS (SPMS) (EDSS increase ≥1.0 point (baseline EDSS ≤ 5.0) or ≥ 0.5 point (baseline EDSS ≥5.5), and ≥1 clinical relapse or ≥1 gadolinium enhanced lesion inthe last 12 months)
MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5before enrollment
Patient has appropriated blood clotting function as assessed by the followinglaboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
Treatment failure (either ≥ 1 relapse, ≥ 1 new T2 lesion, ≥ one gadolinium enhancedlesion or EDSS deterioration) with at least one of MS disease modifying therapy asInterferon-β, Glatiramer acetate (Copaxone), Dimethyl fumarate (Tecfidera),Teriflunomide (Aubagio), Fingolimod (Gilenya), Ozanimod (Zeposia), Cladribine (Mavenclad), Siponimod (Mayzent), Ofatumumab (Kesimpta), or Natalizumab (Tysabri)for more than 6 months
All male patients and female patients with child-bearing potential (between pubertyand 2 years after menopause) should use appropriate contraception method(s) for atleast 4 weeks after UMSC01 treatment
Exclusion
Exclusion Criteria:
Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to,take effective contraceptives measures 4 weeks before and after the treatment.
Patients with uncontrolled diabetes (fasting blood glucose > 250 mg/dL)
Patients with inadequate hepatic and renal function: AST and ALT > 5X ULN; eGFR < 30mL/min.
Patients who are unable to undergo Brain MRI examination for any reason.
Patients who have medical history or current clinically active malignant tumor,peripheral neuropathy, myopathy or other clinically significant neurologicaldiseases that will confound the evaluation of this study.
Patients who have immuno-compromised condition or is with known clinicallysignificantly autoimmune conditions other than MS or is receiving immunosuppressivetreatments other than MS treatment within 6 months.
With active infection that required systemic treatment
Patients who are participating in other clinical trials with an investigationalproduct within 1 month.
Patients who were treated with cytotoxic medications during the last 1 month priorto the infusion.
Relapse of MS within1 month before UMSC01 infusion.
With anti-CD20 therapy, such as rituximab
Patients not suitable to participate the trial as judged by the Investigator(s)
Study Design
Study Description
Connect with a study center
China Medical University Hospital
Taichung, Non-US 404
TaiwanActive - Recruiting

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