Corneal Endothelial Cell DysfunctionPhase 1NCT06726174
Cell Therapy for Corneal Endothelial Cell Dysfunction
A Phase 1 study testing ECCEC in people with Corneal Endothelial Cell Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Culture endothelial cells harvested from donor corneal tissue to treat corneal endothelial cell dysfunction. After ex vivo cultivation, the cells will be injected into anterior chamber and endothelial cells will settle down and adhere to the denuded Descemet's membrane. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Corneal Endothelial Cell Dysfunction
- What is being tested?
- ECCEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Apr 2025to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Patient who's one eye or both eyes diagnosed with corneal endothelial cell dysfunction who met the following inclusion criteria were deemed eligible:
- A BCVA of < 0.5.
- CECs could not be observed via specular microscopy or CEC density was < 500 cells/mm2.
- Corneal edema with a corneal thickness > 650 μm.
- Patient age at the time of obtaining written consent was between 20 and 90 years.
- Written informed consent could be obtained. If both eyes meet the criteria of a. to c., the treatment eye in this trial will be the one with more sever vision impairment which caused by cornea endothelial cell dysfunction.
Who cannot join
- Patients who met the following criteria parameters were deemed ineligible and were excluded from the study.
- Patients with corneal infection (i.e., fungus, bacteria, virus. Etc.).
- The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation.
- The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months.
- Pregnant patients (the urine or blood pregnancy test of woman of childbearing potential* is positive) or patients who had recently given birth and were nursing the newborn child.
- ：A woman of childbearing potential (WOCBP) is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
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- Patients with a hemorrhagic disease (In the patients who is taking Warfarin, the INR is over 3.0.).
- Patients who were judged by the attending physicians to be incapable of understanding the procedure or of providing sufficient corporation due to mental retardation or mental disorder.
- Glaucoma patients with poor IOP control (Patients with maximum dosage of glaucoma medicines (Prostaglandin analogue, beta-blocker, alpha2 agonist, and carbonic anhydrase inhibitor) or after surgery, the IOP cannot be controlled under 25 mmHg.).
- Patients with acute eye infection or inflammation (i.e., bacterial or fungal infection, acute uveitis.)
- Diabetic patients with a poor blood-sugar control (Patients with HbA1c > 10% within the past three months.).
- Patients who were hypersensitive to steroids.
- Patients with systemic autoimmune disease (i.e., systemic lupus erythematosus, Behcet's disease, etc.)
- Patients strongly suspected to have a severe visual disorder due to concomitant other factors.
- Patients who had already received this therapy.
- Patients who had used or were planning to use an anti-cancer drug.
- Patients with a past history of heart disease (i.e., myocardial infarction, heart failure, severe arrhythmia, etc.) or a cerebral vascular disorder.
- Patients for whom it has been determined by the principal investigator or other co-investigators that there will be complications with the patient participating in the study for other reasons.
- Patients who are allergic to the drug or ingredients used in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of Corneal Endothelial Cell Therapy for Corneal Endothelial Cell Dysfunction
Culture endothelial cells harvested from donor corneal tissue to treat corneal endothelial cell dysfunction. After ex vivo cultivation, the cells will be injected into anterior chamber and endothelial cells will settle down and adhere to the denuded Descemet's membrane. Eventually, they will reconstitute functional corneal endothelium to subside the corneal edema and improve the visual acuity.
- Conditions
- Corneal Endothelial Cell Dysfunction
- Being tested
- ECCEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCECDrug
0.5-1x10^6 cells/300 uL, intracameral injection.
| Study group | Role | What they receive |
|---|---|---|
| Cell | Experimental | Not described Receives: Drug: ECCEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEC density
> 500 cells/mm2
Measured: 24-weeks
Secondary outcomes (1)
Corneal thickness
< 650 μm
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start25 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726174
- Sponsor's protocol ID
- 202304098MINB
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Corneal Endothelial Cell Therapy for Corneal Endothelial Cell Dysfunction
- ClinicalTrials.gov ID
- NCT06726174
- Acronym / sponsor ID
- 202304098MINB
- Conditions
- Corneal Endothelial Cell Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Dec 2024 (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.
Culture endothelial cells harvested from donor corneal tissue to treat corneal endothelial cell dysfunction. After ex vivo cultivation, the cells will be injected into anterior chamber and endothelial cells will settle down and adhere to the denuded Descemet's membrane. Eventually, they will reconstitute functional corneal endothelium to subside the corneal edema and improve the visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell | Experimental | Drug: ECCEC |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -
- Patient who's one eye or both eyes diagnosed with corneal endothelial cell dysfunction who met the following inclusion criteria were deemed eligible:
- A BCVA of < 0.5.
- CECs could not be observed via specular microscopy or CEC density was < 500 cells/mm2.
- Corneal edema with a corneal thickness > 650 μm.
Key exclusion criteria (19 listed)
- Patients who met the following criteria parameters were deemed ineligible and were excluded from the study.
- Patients with corneal infection (i.e., fungus, bacteria, virus. Etc.).
- The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation.
- The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months.
- Pregnant patients (the urine or blood pregnancy test of woman of childbearing potential* is positive) or patients who had recently given birth and were nursing the newborn child.
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 |
|---|---|---|
| ECCEC0.5-1x10^6 cells/300 uL, intracameral injection. | Drug | Cell |
Primary outcome
CEC density
Time frame: 24-weeks
> 500 cells/mm2
1 secondary outcome
Corneal thickness
Time frame: 24-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECCEC in people with Corneal Endothelial Cell Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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 Taiwan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEC density (time frame: 24-weeks). It is what the study was designed to measure, not a finding.
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 1 May 2026.