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

Launched by EVER SUPREME BIO TECHNOLOGY CO., LTD. · Sep 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment using umbilical cord stem cells for patients with Multiple Sclerosis (MS). The researchers want to see if giving these stem cells through an intravenous (IV) injection and directly into the spinal fluid (called intrathecal administration) can help patients with MS feel better and potentially recover nerve function. This is important because current medications mainly focus on reducing inflammation but may not help with repairing damaged nerves.

To participate in the trial, you need to be between 20 and 65 years old and have a diagnosis of relapsing-remitting or secondary progressive MS. You should also have tried at least one other MS treatment without success. If you decide to join, you'll need to sign a consent form and follow specific guidelines, such as using birth control if you're able to have children. Throughout the trial, you'll receive monitoring and support from the research team to ensure your safety. This study aims to offer a new approach for those struggling with MS, and participants will help contribute to important medical knowledge.

Gender

ALL

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)