NCT04956744Active, not recruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jun 2021
- Start date
- 31 Aug 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- ImStem Biotechnology
- Diseases
- Multiple sclerosis
- NCT number
- NCT04956744
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 31 Aug 2021 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has history of excluded medications, per protocol, prior to Day 1.
- 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.
- Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.
Other illness
- 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.
- Recent clinically significant infection during the Screening Phase.
- Has any medical or psychiatric condition that would impact outcome or participation in the study.
- Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
Lab values
- Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
- 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.
Other
- Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
- Has an elevated liver function test abnormality during the 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shepherd Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Rocky Mountain MS Clinic Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.