Stem cell shot aims to tame multiple sclerosis
NCT ID NCT04956744
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a single intravenous dose of IMS001, a stem cell product made from human embryonic cells, in 30 adults with multiple sclerosis who have not responded well to standard treatments. The main goal is to see if the treatment is safe and tolerable, while also looking for any signs that it might help control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IMS001 (stem cells from human embryos)
- What this could lead to
- If it works, this could point toward a new treatment option for multiple sclerosis patients who haven't responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 30 people, so it's mainly checking safety. The stem cells may not improve symptoms, and there could be side effects like allergic reactions or lab abnormalities.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103, United States
-
Shepherd Center
Atlanta, Georgia, 30309, United States
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UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
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