Last updated: December 4, 2023
Sponsor: Ever Supreme Bio Technology Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
Control group
Allogeneic umbilical cord mesenchymal stem cells
Clinical Study ID
NCT05532943
ES-CMSC01-D1101
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 in thelast 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) formore 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 neurological diseasesthat 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 prior tothe 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
Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Control group
Phase: 1/2
Study Start date:
September 08, 2023
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
China Medical University Hospital
Taichung, Non-US 404
TaiwanActive - Recruiting
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