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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05532943
Other study ID # ES-CMSC01-D1101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 8, 2023
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source Ever Supreme Bio Technology Co., Ltd.
Contact Sammi Hsu
Phone 886-4-2325-288
Email cthsu@ever-supreme.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 41
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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-ß, 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Allogeneic umbilical cord mesenchymal stem cells
UMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.
Control group
Normal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung Non-US

Sponsors (1)

Lead Sponsor Collaborator
Ever Supreme Bio Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other The exploratory endpoints are listed below for both phase I and IIa portions Immunological markers, including CD3, CD4, CD8 surface markers, IgG, IgM, anti-HLA antibodies and Panel Reactive Antibody Assay in whole blood from visit 2 to 12-month follow-up period
Primary Primary Endpoint for Phase I portion SAE, SUSAR, and AE incidences over the study period from visit 2 to 12-month follow-up period
Primary Primary Endpoint for Phase IIa portion CFB of EDSS to Visit 10 from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB for EDSS of follow up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB for brain MRI parameters of follow-up visits (Visit 6 -10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion Quality of life: CFB for MSQoL-54 questionnaire score of follow-up visits (Visit 6 -10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of T25FW scores of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of 9-HPT scores of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of PASAT scores of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of SDMT scores of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of RNFL thickness, measured by OCT of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoint for phase I portion CFB of MSFC of follow-up visits (Visit 6-10) from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion Time to onset of CDW confirmed by EDSS at least 6 months from visit 2 to 6-month follow-up period
Secondary Efficacy endpoints for phase IIa portion ARR (Annualized relapse rate), where relapse is defined as new or worsening neurological symptoms lasting for >24 hours from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow-up visits (Visit 6 -10) for EDSS from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for brain MRI parameters from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion Quality of life: CFB of follow up visits (Visit 6-10) for MSQoL-54 questionnaire score from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for T25FW scores from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for 9-HPT scores from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for PASAT scores from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for SDMT scores from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for RNFL thickness, measured by OCT from visit 2 to 12-month follow-up period
Secondary Efficacy endpoints for phase IIa portion CFB of follow up visits (Visit 6-10) for MSFC from visit 2 to 12-month follow-up period
Secondary The safety endpoints are listed below for both phase I and IIa portions SAE, SUSAR, and AE incidences over the study period from visit 2 to 12-month follow-up period
Secondary The safety endpoints are listed below for both phase I and IIa portions CFB of laboratory data to subsequent visits from visit 2 to 12-month follow-up period
Secondary The safety endpoints are listed below for both phase I and IIa portions CFB of physical examination to subsequent visits from visit 2 to 12-month follow-up period
Secondary The safety endpoints are listed below for both phase I and IIa portions CFB of vital signs to subsequent visits from visit 2 to 12-month follow-up period
Secondary The safety endpoints are listed below for both phase I and IIa portions CFB of AFP, CEA, CA199, SCC, IgA, anti-EBV, ß-HCG, CA125, CA153, and PSA to Visit 6 (Phase I) or Visit 10 (Phase IIa) from visit 2 to 12-month follow-up period
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