Using stem cells from umbilical cords to treat multiple sclerosis

A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis

This study is testing if using stem cells from umbilical cords can safely help people with multiple sclerosis feel better when combined with their usual treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Ever Supreme Bio Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Ofatumumab, Natalizumab, rituximab
• Locations: 1 site (Taichung, Non-US)
• Trial ID: NCT05532943 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of allogeneic umbilical cord mesenchymal stem cells (UMSC01) administered both intravenously and intrathecally in patients with multiple sclerosis (MS). The trial consists of a Phase I component, where six patients will be monitored for safety after receiving the treatment, followed by a Phase IIa component that includes a sham-controlled group and a treatment group. The aim is to assess not only the safety of the stem cell therapy but also its potential therapeutic benefits in conjunction with conventional MS treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 65 with a diagnosis of relapsing-remitting or secondary progressive multiple sclerosis who have experienced treatment failure with existing therapies.

Not a fit: Patients with other forms of MS or those who do not meet the specific inclusion criteria, such as age or EDSS score, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to improve recovery and neuroregeneration in patients with multiple sclerosis.

How similar studies have performed: While the use of stem cells in treating MS is an emerging field, similar studies have shown promise, but this specific approach remains novel.

Eligibility criteria

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 the past 12 months, ≥2 clinically documented relapses in the last 24 months or ≥ 1 gadolinium enhanced lesion or T2 new lesion in the last 12 months) or Secondary Progressive 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 the last 12 months)
4. MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5 before enrollment
5. Patient has appropriated blood clotting function as assessed by the following laboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
6. Treatment failure (either ≥ 1 relapse, ≥ 1 new T2 lesion, ≥ one gadolinium enhanced lesion or EDSS deterioration) with at least one of MS disease modifying therapy as Interferon-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
7. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after UMSC01 treatment

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 \< 30 mL/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 diseases that will confound the evaluation of this study.
6. Patients who have immuno-compromised condition or is with known clinically significantly autoimmune conditions other than MS or is receiving immunosuppressive treatments 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 investigational product within 1 month.
9. Patients who were treated with cytotoxic medications during the last 1 month prior to the 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)

Where this trial is running

Taichung, Non-US

• China Medical University Hospital — Taichung, Non-US, Taiwan (Recruiting)

Study contacts

• Study coordinator: Sammi Hsu

Conditions Multiple Sclerosis