oGVHDNCT07210619
Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
A study testing d-MAPPS in people with oGVHD, run by Regenerative Ocular Immunobiologics LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- oGVHD
- What is being tested?
- d-MAPPS
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the detailed description
Regenerative Ocular Immunobiologics, LLC ("ROI") is committed to advancing innovative regenerative biologics for serious ocular conditions with high unmet medical need. The investigational product, d-MAPPS™ Ophthalmic Solution, is currently being evaluated in clinical trials under U.S. FDA Investigational New Drug (IND) #030066. Clinical trial participation remains the preferred and primary pathway for patient access. ROI has established this Expanded Access Policy in accordance with Section 561A of the FDCA to outline conditions under which d-MAPPS™ may be considered outside of a clinical trial.
At this stage of development, d-MAPPS™ is not approved by the FDA. Participation in a clinical trial is the preferred mechanism for accessing this investigational treatment, as trials are designed to evaluate safety and effectiveness in a controlled setting.
Certain patients with serious or immediately life-threatening conditions may not meet eligibility criteria for clinical trials and may pursue access to investigational therapies. In accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act, Regenerative Ocular Immunobiologics has established the following Expanded Access (EA) policy:
This Expanded Access Policy describes the conditions under which Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) may be made available to patients outside of a clinical trial, in accordance with U.S. FDA regulations.
Availability
- Expanded Access to d-MAPPS™ may be considered for patients with severe chronic ocular GVHD who have no satisfactory alternative treatment options and who are not eligible for ongoing clinical trials.
- Expanded Access is not guaranteed and remains subject to review of patient circumstances, clinical data, and drug supply.
Request Procedures Treating ophthalmologists or eye care professionals may submit Expanded Access requests to info@roiglobalsolutions.org.
Requests should include relevant patient history, diagnosis, rationale for Expanded Access, and a proposed monitoring plan.
Criteria for Consideration
Requests will be evaluated on the following:
- Seriousness of the patient's condition
- Lack of satisfactory therapeutic alternatives
- Ineligibility for ongoing clinical trials
- Whether potential benefit justifies potential risk of the investigational product
- Adequate drug supply
Review and Response Timeline Regenerative Ocular Immunobiologics will acknowledge receipt of EA requests within 5 business days and will provide a decision as promptly as possible while following all FDA requirements. All requests will be reviewed in accordance with FDA regulations and company policy.
Cost of Treatment ROI does not currently intend to charge patients for d-MAPPS™ provided through Expanded Access. ROI reserves the right to recover direct costs in accordance with FDA regulations should circumstances change.
Policy Updates
This Expanded Access Policy will be reviewed and updated as needed. The most current version will be available at:
https://www.roiglobalsolutions.org/
- Conditions
- oGVHD
- Being tested
- d-MAPPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-MAPPSDrug
Ophthalmic Solution for oGVHD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for oGVHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regenerative Ocular Immunobiologics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210619
- Sponsor's protocol ID
- 30066-EA
- Status last verified
- Oct 2025
- First submitted
- 29 Sep 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
- ClinicalTrials.gov ID
- NCT07210619
- Acronym / sponsor ID
- 30066-EA
- Conditions
- oGVHD
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Regenerative Ocular Immunobiologics LLCIndustry (pharma, biotech, devices)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Regenerative Ocular Immunobiologics, LLC ("ROI") is committed to advancing innovative regenerative biologics for serious ocular conditions with high unmet medical need. The investigational product, d-MAPPS™ Ophthalmic Solution, is currently being evaluated in clinical trials under U.S. FDA Investigational New Drug (IND) #030066. Clinical trial participation remains the preferred and primary pathway for patient access. ROI has established this Expanded Access Policy in accordance with Section 561A of the FDCA to outline conditions under which d-MAPPS™ may be considered outside of a clinical trial.
At this stage of development, d-MAPPS™ is not approved by the FDA. Participation in a clinical trial is the preferred mechanism for accessing this investigational treatment, as trials are designed to evaluate safety and effectiveness in a controlled setting.
Certain patients with serious or immediately life-threatening conditions may not meet eligibility criteria for clinical trials and may pursue access to investigational therapies. In accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act, Regenerative Ocular Immunobiologics has established the following Expanded Access (EA) policy:
This Expanded Access Policy describes the conditions under which Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) may be made available to patients outside of a clinical trial, in accordance with U.S. FDA regulations.
Availability
- Expanded Access to d-MAPPS™ may be considered for patients with severe chronic ocular GVHD who have no satisfactory alternative treatment options and who are not eligible for ongoing clinical trials.
- Expanded Access is not guaranteed and remains subject to review of patient circumstances, clinical data, and drug supply.
Request Procedures Treating ophthalmologists or eye care professionals may submit Expanded Access requests to info@roiglobalsolutions.org.
Requests should include relevant patient history, diagnosis, rationale for Expanded Access, and a proposed monitoring plan.
Criteria for Consideration
Requests will be evaluated on the following:
- Seriousness of the patient's condition
- Lack of satisfactory therapeutic alternatives
- Ineligibility for ongoing clinical trials
- Whether potential benefit justifies potential risk of the investigational product
- Adequate drug supply
Review and Response Timeline Regenerative Ocular Immunobiologics will acknowledge receipt of EA requests within 5 business days and will provide a decision as promptly as possible while following all FDA requirements. All requests will be reviewed in accordance with FDA regulations and company policy.
Cost of Treatment ROI does not currently intend to charge patients for d-MAPPS™ provided through Expanded Access. ROI reserves the right to recover direct costs in accordance with FDA regulations should circumstances change.
Policy Updates
This Expanded Access Policy will be reviewed and updated as needed. The most current version will be available at:
https://www.roiglobalsolutions.org/
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-MAPPSOphthalmic Solution for oGVHD | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Website for ROI GlobalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing d-MAPPS in people with oGVHD, run by Regenerative Ocular Immunobiologics LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marissa Harrell, PhD (727-748-0420, info@roiglobalsolutions.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.