Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

NCT07210619 | Unknown

• 1 other identifier: 30066-EA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) - available to patients outside of a clinical trial, in accordance with U.S. FDA regulations, including section 561A of the Federal Food, Drug, and Cosmetic Act (FDCA).

Conditions

oGVHD

Interventions

d-MAPPS DRUG

Ophthalmic Solution for oGVHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regenerative Ocular Immunobiologics LLC: lead

Related Links

• Website for ROI Global

Central Study Contacts

Marissa Harrell, PhD

CONTACT

727-748-0420; info@roiglobalsolutions.org

Craig Hull

CONTACT

7277480420; info@roiglobalsolutions.org

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10