A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
A Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs)
1 other identifier
interventional
30
1 country
3
Brief Summary
This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-sclerosis
Started Aug 2021
Longer than P75 for phase_1 multiple-sclerosis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedStudy Start
First participant enrolled
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 8, 2026
April 1, 2026
6.3 years
June 22, 2021
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability
Frequency of treatment-emergent adverse events (TEAEs).
Day 1 to Month 60
Safety and tolerability
Clinically significant laboratory abnormalities.
Day 1 to Month 60
Study Arms (3)
Low Dose
EXPERIMENTALLow dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
High Dose
EXPERIMENTALHigh dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
Optional Dose
EXPERIMENTALHigh dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
Interventions
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
Eligibility Criteria
You may qualify if:
- Provides signed and dated informed consent in accordance with local regulations.
- to 65 years of age.
- Diagnosis of MS.
- Has had an inadequate response DMTs.
- EDSS within protocol parameters.
- Able and willing to undergo MRIs.
- Must be clinically stable for 1 month prior to Day 1.
You may not qualify if:
- Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
- Has history of excluded medications, per protocol, prior to Day 1.
- Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin that has been excised with clean margins, or adequately treated in-situ carcinoma of the cervix.
- Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.
- Prior treatment with any allogeneic cell therapy or tissue transplant.
- Prior history of smoking equivalent to ˃20 cumulative pack years of cigarettes.
- Recent clinically significant infection during the Screening Phase.
- Has any medical or psychiatric condition that would impact outcome or participation in the study.
- Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
- Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
- Has an elevated liver function test abnormality during the Screening Phase.
- Has abnormalities of blood count during the Screening Phase.
- Has laboratory abnormalities of renal function during the Screening Phase.
- Has other clinically significant laboratory abnormalities during Screening Phase.
- Body weight ≥120 kg.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shepherd Center
Atlanta, Georgia, 30309, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Kim, MD
ImStem Biotechnology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2021
First Posted
July 9, 2021
Study Start
August 31, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04