Stem cells aim to soothe dry eyes in transplant patients

NCT ID NCT06905834

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether injecting stem cells into the eye can help people with severe dry eye caused by graft-versus-host disease (GVHD), a complication of bone marrow transplants. The trial will include 30 adults who have not improved with standard treatments. Participants will receive either a low or high dose of stem cells, and researchers will measure changes in eye surface health, tear production, and symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mesenchymal stem cells (from donor fat tissue)
What this could lead to
If it works, this could offer a new treatment option for severe dry eye in GVHD patients who haven't responded to standard therapies.
What could go wrong
This is a small, early-phase trial (30 people) testing safety and effectiveness. The treatment may not work for everyone, and side effects from the injection or cells are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Patients over 18 years of age who understand and sign the informed consent form. * Diagnosis of severe GVHD (graft versus host disease) according to NIH criteria (revised by Lee SJ in 2017) with ocular involvement in the form of severe SOD (severe ocular disease) in both eyes for more than 3 months, objectively defined as superficial punctate keratitis \>2 on the Oxford scale (range 0-5) and/or the presence of epithelial defect, and subjectively as severe symptoms, \>33 points on the OSDI questionnaire (0-100). * Patients must have previously been treated for at least three months with blood derivatives and/or insulin eye drops and topical cyclosporine or tacrolimus (unless any of these treatments were not tolerated and had to be discontinued). * Patients must be using ocular lubricants at least 4 times a day and, despite this, still meet the criteria for severe SOD as outlined in point 2. * Patients on low doses of topical corticosteroids for maintenance should have a stable dose for at least one month prior to inclusion. * The dose and frequency of all topical medications the patient begins the trial with must remain unchanged throughout the duration of the trial, unless otherwise judged by the investigator. * The chronic GVHD systemic treatment should be stable regarding the use of systemic immunosuppressors for at least one month prior to patient inclusion or before starting treatment. * Negative result in the urine pregnancy test at the baseline visit for women of childbearing age. Subjects must be advised to use contraceptive methods during their participation in the clinical trial and undergo a new pregnancy test at the treatment visit if more than 28 days have passed since the baseline visit. Exclusion Criteria: * Uncontrolled systemic disease or any condition that, in the medical judgment, could put the patient at risk or affect the interpretation of the results. * Uncontrolled systemic GVHD. * Active ocular infection. * Ocular surgery within the last 3 months. * Initiation of topical therapies for SOD indicated in the inclusion criteria less than 3 months prior to inclusion. * Start of topical corticosteroid use within 4 weeks prior to inclusion. * Cognitive impairments that could interfere with study compliance. * Pregnant women or women during the lactation period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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