A Study of IMS001 in Patients With Multiple Sclerosis

November 9, 2026 updated by: Zhuhai Hengqin ImStem Biotechnology Co., Ltd.

A Clinical Study of IMS001 Injection (Human Embryonic Stem Cell-Derived Mesenchymal-Like Stem Cells) for the Treatment of Multiple Sclerosis

This study will evaluate the safety and tolerability of IMS001 and explore its possible effects in adults with multiple sclerosis. IMS001 is an investigational cell therapy consisting of mesenchymal-like stem cells derived from human embryonic stem cells.

The study plans to enroll 4 adults aged 18 to 65 years with relapsing-remitting or secondary progressive multiple sclerosis in China. Each participant will receive a single infusion of IMS001 into a vein. All participants will receive IMS001, and both participants and the study team will know which treatment is given.

Participants will undergo screening for up to 4 weeks before treatment. After the infusion, they will be assessed over 12 months for side effects and changes in multiple sclerosis, including relapses, disability, brain magnetic resonance imaging (MRI) findings, vision, movement, and thinking abilities.

Participants will then enter an additional 24-month follow-up period to monitor long-term safety, including serious side effects and possible tumor development. Total participation may last up to 37 months, including screening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntarily provides written informed consent.

  2. Aged 18 to 65 years, inclusive, of either sex.

  3. Has relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), diagnosed according to the 2017 McDonald criteria.

  4. Has an Expanded Disability Status Scale (EDSS) score of 3.0 to 7.5, inclusive.

  5. Has experienced at least one of the following despite disease-modifying therapy (DMT):

    • One relapse within the year before screening, or at least two relapses within the two years before screening.
    • Confirmed disability progression, as assessed by the investigator.
    • Gadolinium-enhancing T1 lesions and/or new or enlarging T2 lesions on magnetic resonance imaging (MRI).

  6. Has had no clinical relapse within one month before screening.

  7. Has had multiple sclerosis for more than one year.

  8. Women of childbearing potential must agree to use effective contraception during the study and for six months after the last dose of study treatment, and must have negative pregnancy tests at screening and baseline.

  9. Male participants with partners of childbearing potential must agree to use effective contraception for three months after the last dose of study treatment and must not donate sperm during this period.

  10. Is able and willing to undergo gadolinium administration and repeated MRI examinations.

Exclusion Criteria:

  1. Known or suspected allergy to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any component of IMS001.
  2. Use of teriflunomide within 12 months before screening, unless an 11-day elimination procedure using cholestyramine or another appropriate elimination agent has been completed.
  3. Use of alemtuzumab within 12 months before screening, or cladribine, rituximab, ocrelizumab, or another anti-CD20 monoclonal antibody within six months before screening.
  4. Use of ofatumumab, natalizumab, or ozanimod, or treatment with plasma exchange, within three months before screening.
  5. Use of mitoxantrone, cyclophosphamide, azathioprine, methotrexate, cyclosporine, mycophenolate mofetil, fingolimod, siponimod, ponesimod, or systemic corticosteroids within one month before screening.
  6. Use of interferon beta-1a/1b, glatiramer acetate, dimethyl fumarate, diroximel fumarate, or monomethyl fumarate within two weeks before screening. Generic equivalents of glatiramer acetate and dimethyl fumarate are included.
  7. Previous treatment with any allogeneic cell therapy or tissue transplantation.
  8. History of a neoplastic disease, except basal cell carcinoma; nonmetastatic cutaneous squamous cell carcinoma excised with clear margins; adequately treated cervical carcinoma in situ; or low-risk differentiated papillary thyroid carcinoma or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) that has been definitively treated, without recurrence, and meets the required disease-free survival criteria.
  9. Clinically significant electrocardiogram abnormalities during screening.
  10. Known or documented HIV or syphilis infection, or active hepatitis B or hepatitis C infection.
  11. Abnormal liver function, including total bilirubin greater than 2 times the upper limit of normal (ULN), except isolated Gilbert syndrome, or AST or ALT greater than 3 times ULN.
  12. White blood cell count below 3 × 10^9/L; lymphocyte count below 0.8 × 10^9/L; hemoglobin below 90 g/L; or platelet count below 80 × 10^9/L.
  13. Estimated glomerular filtration rate below 30 mL/min/1.73 m² during screening, calculated using the 2021 CKD-EPI equation; acute kidney injury; need for renal replacement therapy; or another clinically significant active or unstable kidney disease, as judged by the investigator.
  14. History of another autoimmune disease, myelodysplasia, or a hematological disease.
  15. Pregnancy, breastfeeding, or plans to become pregnant during the study.
  16. Inability to receive study treatment during the trial, likely noncompliance with the protocol, or any other circumstance considered unsuitable by the investigator.
  17. Participation in another clinical trial of a drug or device within three months before enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMS001 Treatment

All 4 participants will receive a single intravenous infusion of IMS001 at the same dose level.
Biological: IMS001

IMS001 is a human embryonic stem cell-derived mesenchymal-like stem cell product. Each participant will receive a single intravenous infusion at a dose of 1 × 10^6 cells/kg on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With IMS001-Related Adverse Events
Time Frame: From IMS001 infusion on Day 1 through Month 12

Number of participants who experience at least one adverse event assessed by the investigator as related to IMS001. Events will be summarized by type, severity, seriousness, and relationship to treatment.
From IMS001 infusion on Day 1 through Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuhai Hengqin ImStem Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 9, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 9, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMS001-01
  • ChiCTR2600129418 (Registry Identifier: Chinese Clinical Trial Registry (ChiCTR))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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