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Stem cell shot aims to tame multiple sclerosis

NCT ID NCT04956744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Aug 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

Anyone

Healthy volunteers

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

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

  • Rocky Mountain MS Clinic

    Salt Lake City, Utah, 84103, United States

  • Shepherd Center

    Atlanta, Georgia, 30309, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605, United States

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