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Evaluation of Mesenchymal Stem Cell Eye Injections for Dry Eye Disease in Patients with Graft-versus-Host Disease Who Haven't Responded to Standard Treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is evaluating the effectiveness and safety of Allogeneic Mesenchymal Stem Cell (MSC) eye injections for treating dry eye disease in patients with Graft-versus-Host Disease (GvHD). Graft-versus-Host Disease is a condition that can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient's body. When it affects the eyes, it can cause severe dry eye disease, which includes symptoms like eye irritation, burning, and vision problems.

The purpose of this study is to determine if subconjunctival (under the eye's membrane) injections of stem cells can improve the signs and symptoms of severe dry eye disease that hasn't responded to conventional treatments. The study will test two different doses of stem cells (6.25 million and 12.5 million) to see which works better.

During the trial, participants will receive ASC (adipose-derived stem cell) injections in their eyes and will be monitored for improvements in various aspects of eye health, including the integrity of the eye surface, tear production, redness of the eye membrane, and function of the oil-producing glands in the eyelids. Researchers will also collect tear and blood samples to analyze inflammation markers and identify potential new ways to track disease improvement.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Visit and Treatment

    After joining the study, you will receive a subconjunctival injection (an injection under the membrane covering your eye) of allogeneic adipose-derived adult mesenchymal stem cells (eASC). These are stem cells derived from fat tissue of donors that can help reduce inflammation.

    Depending on which treatment group you are assigned to, you will receive either a low dose (6.25 million stem cells) or a high dose (12.5 million stem cells) in both eyes.

    Before receiving the treatment, if you are a woman of childbearing potential, you will need to take a pregnancy test if more than 28 days have passed since your baseline assessment.

  2. Step 2

    Continuing Current Medications

    Throughout the trial, you will continue using your current ocular lubricants at least 4 times daily as you were before joining the study.

    Any other eye medications you were using before the trial (such as blood derivatives, insulin eye drops, topical cyclosporine or tacrolimus) will be continued at the same dosage.

    If you are on topical corticosteroids, you will maintain the same stable dose that you were on for at least one month prior to joining the trial.

    Your systemic medications for chronic Graft-versus-Host Disease will remain unchanged from what you were taking for at least one month before joining the study.

  3. Step 3

    Follow-up Assessments

    During follow-up visits, several measurements will be taken to evaluate how well the treatment is working:

    Your corneal surface will be examined using fluorescein staining to check for improvements in superficial punctate keratitis (small dots of damage on the cornea) and any epithelial defects (areas where the cornea's surface layer is damaged).

    Tear production will be measured using the Schirmer test, which involves placing a small strip of filter paper under your lower eyelid after applying topical anesthetic.

    The redness of your eyes (conjunctival hyperemia) will be evaluated using the Efron scale.

    Your Meibomian glands (oil-producing glands in your eyelids) will be assessed.

    The central cornea will be examined using in vivo confocal microscopy, which provides detailed images of your cornea to check for changes in the epithelial cells, dendritic cells, and nerve structures.

    You will complete several questionnaires to assess your symptoms, including the OSDI (Ocular Surface Disease Index), mSIDEQ, NRS, WFPRS, and CDES-Q.

  4. Step 4

    Sample Collection

    Tear samples will be collected to analyze the presence and concentration of 48 inflammation-related molecules.

    Blood samples will also be taken to measure the same inflammatory markers in your serum.

    These samples will help researchers understand how the treatment is affecting the inflammatory response in your eyes and body.

  5. Step 5

    Monitoring for Side Effects

    Throughout the trial, you will be monitored for any adverse events related to the stem cell injection.

    It's important to report any new symptoms or changes in your condition to the study team during your follow-up visits.

  6. Step 6

    Trial Completion

    The clinical trial is expected to run until June 30, 2028, though your individual participation may not last this entire period.

    At the end of your participation, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment for your dry eye disease related to Graft-versus-Host Disease.

Who can join the trial?

10 criteria

  • You must be over 18 years old and able to understand and sign the informed consent form.
  • You must have severe chronic Graft versus Host Disease (cGVHD) with severe dry eye disease in both eyes that has lasted more than 3 months.
  • Your dry eye condition must be objectively confirmed by a score higher than 2 on the Oxford scale (a test that measures damage to the eye surface) and/or have an epithelial defect (damage to the eye's surface layer).
  • You must have severe dry eye symptoms, scoring more than 33 points on the OSDI questionnaire (a survey that measures dry eye severity).
  • You must have previously been treated for at least three months with blood derivatives (like serum eye drops) and/or insulin eye drops and topical cyclosporine or tacrolimus, unless you couldn't tolerate these treatments.
  • You must be using artificial tears or lubricating eye drops at least 4 times a day and still have severe dry eye symptoms.
  • If you're using topical corticosteroids (steroid eye drops), you must have been on a stable dose for at least one month before joining the study.
  • You must be able to maintain the same doses and frequency of all your eye medications throughout the trial, unless your doctor determines a change is needed.
  • Your systemic treatment for chronic GVHD must have been stable for at least one month before joining the study.
  • If you're a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use contraception during the study.

Who cannot join the trial?

9 criteria

  • People who are pregnant or breastfeeding cannot participate.
  • If you have an eye infection or inflammation that is not related to your condition, you cannot join the study.
  • If you have had eye surgery in the past 3 months, you are not eligible.
  • People with severe damage to the surface of the eye (called corneal ulceration) cannot participate.
  • If you have uncontrolled glaucoma (high pressure in the eye that can damage vision), you cannot join.
  • People with active eye cancer are excluded from the study.
  • If you have a known allergy to the study medication or its components, you cannot participate.
  • People who are currently participating in another clinical trial cannot join this study.
  • If you have a condition that the study doctor believes would interfere with the study or put your health at risk, you may be excluded.
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Investigated drugs

Mesenchymal Stem Cells (MSC) are special cells that can help repair damaged tissues. In this trial, these stem cells are injected into the eye to treat severe dry eye disease caused by Graft-versus-Host Disease (GvHD). GvHD is a condition that can occur after a bone marrow or stem cell transplant when the donor cells attack the recipient's body. The stem cells used in this treatment are allogeneic, which means they come from a donor rather than the patient's own body.

What is already known about the treatment

Mesenchymal Stem Cells (MSCs) – These are specialized cells administered via subconjunctival injection (under the conjunctiva of the eye) to treat severe dry eye disease in patients with chronic Graft-versus-Host Disease (cGVHD). MSCs work by modulating the immune response and promoting tissue repair through their anti-inflammatory and regenerative properties. They're currently being investigated in Phase IIB clinical trials for patients whose condition has not responded to conventional treatments. This experimental therapy aims to reduce inflammation and restore normal tear film function by potentially differentiating into functional tissue cells and secreting growth factors that support healing.

Investigated diseases

  • Dry eye disease

    A condition characterized by a lack of adequate lubrication and moisture on the surface of the eye. It occurs when tears are not able to provide adequate lubrication, either because of insufficient tear production or increased tear evaporation. The condition can lead to inflammation and damage to the surface of the eye, resulting in discomfort, visual disturbances, and potential damage to the ocular surface. Symptoms typically include a scratchy sensation, burning, redness, and blurred vision that may worsen throughout the day.

  • Chronic Graft versus Host Disease (cGVHD)

    A long-term complication that can occur after allogeneic stem cell or bone marrow transplantation. In this condition, the donor's immune cells recognize the recipient's tissues as foreign and attack them. cGVHD can affect various organs, including the eyes, skin, mouth, liver, lungs, and digestive tract. When it affects the eyes, it often causes severe dry eye disease due to inflammation and scarring of the lacrimal glands that produce tears. The ocular manifestations typically develop gradually and may progress to cause significant discomfort and visual impairment.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519772-10-00Protocol codeTERAV_24-01_EICRxEYEEstimated enrolment30 patientsSponsorFundacion De Investigacion Biomedica De Salamanca

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