Limbal Stem Cell Deficiency (LSCD)NCT07422389
BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency
A study testing BRM421 Ophthalmic Solution, 0.06% in people with Limbal Stem Cell Deficiency (LSCD), run by BRIM Biotechnology Inc. at 1 site in United States.
Trial summary
The goal of this program is to provide patients with Limbal Stem Cell Deficiency access to the BRM421 eye drops. Participants will: Use BRM421 two times a day for at least 12 weeks Visit the clinic monthly for checkups and tests Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limbal Stem Cell Deficiency (LSCD)
- What is being tested?
- BRM421 Ophthalmic Solution, 0.06%
- How many people
- Not given
- Where
- 1 siteUnited States
- 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
- Adult patients with mild to moderate LSCD who unsatisfied with the standard of care treatments and who seek the treatment with BRM421 Ophthalmic Solution. Patients scheduled for LSC transplant may be included, but treatment with BRM421 should begin only after the surgery.
- Be able to sign the informed consent and follow with investigator instructions.
- If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner) and have a negative urine pregnancy test at the time of consent.
Who cannot join
- The patients eligible for the BRIM clinical trial(s).
- The patients diagnosed with primary LSCD which is the genetic mutations that lead to LSC dysfunction or destruction.
- Have a condition or a situation in which the investigator feels the patients is not suitable and may put the patient at significant risk.
- Be a female who is pregnant, nursing, or planning a pregnancy at the time of consent. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of BRM421 among pregnant patients are not known.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104
Bennie Jeng, MD
About this study
Official title: Intermediate-Size Patient Population Use of BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency
The goal of this program is to provide patients with Limbal Stem Cell Deficiency access to the BRM421 eye drops.
Participants will:
- Use BRM421 two times a day for at least 12 weeks
- Visit the clinic monthly for checkups and tests
- Conditions
- Limbal Stem Cell Deficiency (LSCD)
- Being tested
- BRM421 Ophthalmic Solution, 0.06%
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRM421 Ophthalmic Solution, 0.06%Drug
Patients eligible to participate will receive 0.06% BRM421 Ophthalmic Solutions to be administered two times daily (BID, morning and bedtime) on the eligible eye(s). The administration will be at least 12 weeks. The investigator may continue the treatment beyond the 12 weeks based on clinical response. For patients scheduled for LSC transplant, treatment with BRM421 should start only after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem Cell Deficiency (LSCD)Studies 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
- BRIM Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422389
- Sponsor's protocol ID
- 859634
- Other IDs
- BRM421-25-EA002
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-Size Patient Population Use of BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT07422389
- Acronym / sponsor ID
- 859634
- Conditions
- Limbal Stem Cell Deficiency (LSCD)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- BRIM Biotechnology Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- First posted
- 20 Feb 2026 (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.
The goal of this program is to provide patients with Limbal Stem Cell Deficiency access to the BRM421 eye drops.
Participants will:
- Use BRM421 two times a day for at least 12 weeks
- Visit the clinic monthly for checkups and tests
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with mild to moderate LSCD who unsatisfied with the standard of care treatments and who seek the treatment with BRM421 Ophthalmic Solution. Patients scheduled for LSC transplant may be included, but treatment with BRM421 should begin only after the surgery.
- Be able to sign the informed consent and follow with investigator instructions.
- If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner) and have a negative urine pregnancy test at the time of consent.
Key exclusion criteria (4 listed)
- The patients eligible for the BRIM clinical trial(s).
- The patients diagnosed with primary LSCD which is the genetic mutations that lead to LSC dysfunction or destruction.
- Have a condition or a situation in which the investigator feels the patients is not suitable and may put the patient at significant risk.
- Be a female who is pregnant, nursing, or planning a pregnancy at the time of consent. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of BRM421 among pregnant patients are not known.
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 |
|---|---|---|
| BRM421 Ophthalmic Solution, 0.06%Patients eligible to participate will receive 0.06% BRM421 Ophthalmic Solutions to be administered two times daily (BID, morning and bedtime) on the eligible eye(s). The administration will be at least 12 weeks. The investigator may continue the treatment beyond the 12 weeks based on clinical response. For patients scheduled for LSC transplant, treatment with BRM421 should start only after surgery. | 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 20 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRM421 Ophthalmic Solution, 0.06% in people with Limbal Stem Cell Deficiency (LSCD), run by BRIM Biotechnology Inc. at 1 site in United States.
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 3 inclusion and 4 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Emma Iacobucci (215-662-9393, emma.iacobucci@pennmedicine.upenn.edu), 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 20 Feb 2026.