Multiple SclerosisPhase 1NCT04956744
A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis
A Phase 1 study testing IMS001 in people with Multiple Sclerosis, run by ImStem Biotechnology at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- IMS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2021to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides signed and dated informed consent in accordance with local regulations.
- 18 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Women pregnant, breast feeding, or planning to become pregnant during the study.
- Is unavailable for the duration of the trial, is likely to be noncompliant with the protocol, or is generally felt to be unsuitable by the principal investigator.
- Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shepherd Center
Atlanta, Georgia, 30309
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: 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)
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.
- Conditions
- Multiple Sclerosis
- Being tested
- IMS001
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMS001Biological
IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. Receives: Biological: IMS001 |
| High Dose | Experimental | High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. Receives: Biological: IMS001 |
| Optional Dose | Experimental | High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6. Receives: Biological: IMS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Frequency of treatment-emergent adverse events (TEAEs).
Measured: Day 1 to Month 60
Safety and tolerability
Clinically significant laboratory abnormalities.
Measured: Day 1 to Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start31 Aug 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImStem Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kim, MD, Study director, ImStem Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956744
- Sponsor's protocol ID
- IMS001-01
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04956744
- Acronym / sponsor ID
- IMS001-01
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ImStem BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: IMS001Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. |
| High Dose | Experimental | Biological: IMS001High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1. |
| Optional Dose | Experimental | Biological: IMS001High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provides signed and dated informed consent in accordance with local regulations.
- 18 to 65 years of age.
- Diagnosis of MS.
- Has had an inadequate response DMTs.
- EDSS within protocol parameters.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMS001IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). | Biological | High Dose, Low Dose, Optional Dose |
Primary outcome
Safety and tolerability
Time frame: Day 1 to Month 60
Frequency of treatment-emergent adverse events (TEAEs).
Safety and tolerability
Time frame: Day 1 to Month 60
Clinically significant laboratory abnormalities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Imstem BiotechnologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Kim, MD study director
ImStem Biotechnology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMS001 in people with Multiple Sclerosis, run by ImStem Biotechnology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Day 1 to Month 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.