New hope for chronic dry eye from Graft-Versus-Host disease: expanded access to d-MAPPS eye drops
NCT ID NCT07210619
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This expanded access program makes an investigational eye drop called d-MAPPS available to adults with chronic ocular graft-versus-host disease (oGVHD), a painful dry eye condition that can occur after a stem cell or bone marrow transplant. The treatment is a protein-based solution derived from donor cells. Participants must have moderate to severe symptoms and be in stable overall health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- d-MAPPS ophthalmic solution (a protein-based eye drop derived from donor cells)
- What this could lead to
- If successful, this expanded access program could provide a new treatment option for people with chronic dry eye caused by graft-versus-host disease.
- What could go wrong
- This is an expanded access program, not a full clinical trial, so data on effectiveness and safety is still limited. The treatment may not work for everyone and could have side effects.
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Study facts
What this study's own registry entry says, in plain language.
- 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
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18 years and older
- Sex
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Anyone
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: * Age ≥18 years. * Willing and able to provide written informed consent. * Willing and able to comply with study assessments for the full duration of the study. * Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual. * Minimum Oxford Schema grade of ≥1 in at least one eye. * OSDI score of ≥22. * UNC DEMS score of ≥3. * In good stable overall health * Note: If the patient has no exclusion criteria, investigator can combine the Pre-screen and Baseline visit Exclusion Criteria: * History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Ocular or periocular malignancy. * Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry. * Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month. * Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry. * Current use of topical steroids more than twice a day. * Corneal epithelial defect \>1mm2. * Any history of herpetic keratitis. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Participation in another simultaneous medical research study. * Signs of current infection, including fever and current treatment with antibiotics. * All vaccinations including COVID are prohibited during this study. * Intra-ocular surgery or ocular laser surgery within 3 months. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution following surgery.) * Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.) * Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
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The study's own enquiry address
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The official record
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
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