Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis

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

This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients are willing to sign informed consent.
  2. Male or female are age between 20 to 65 years old on date of consent.
  3. 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)
  4. MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5before enrollment
  5. Patient has appropriated blood clotting function as assessed by the followinglaboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
  6. 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
  7. 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:

  1. 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.
  2. Patients with uncontrolled diabetes (fasting blood glucose > 250 mg/dL)
  3. Patients with inadequate hepatic and renal function: AST and ALT > 5X ULN; eGFR < 30mL/min.
  4. Patients who are unable to undergo Brain MRI examination for any reason.
  5. 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.
  6. 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.
  7. With active infection that required systemic treatment
  8. Patients who are participating in other clinical trials with an investigationalproduct within 1 month.
  9. Patients who were treated with cytotoxic medications during the last 1 month prior tothe infusion.
  10. Relapse of MS within1 month before UMSC01 infusion.
  11. With anti-CD20 therapy, such as rituximab
  12. 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

There is single arm in Phase I part: 6 patients will be enrolled sequentially for safety considerations. The patient will receive UMSC01 via IV followed by IT at day 28 as described in above. After all patients in Phase I complete the safety assessment by SMC without any major safety issue 4 weeks after the last UMSC01 administration, the Phase IIa part will be initiated. There are 2 arms in Phase IIa part: Sham-controlled with conventional treatment control and administration of UMSC01 with conventional treatment.

Connect with a study center

  • China Medical University Hospital

    Taichung, Non-US 404
    Taiwan

    Active - Recruiting

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