Clinical trial NCT06726174: Cell Therapy for Corneal Endothelial Cell Dysfunction
Official title: Phase I Clinical Trial of Corneal Endothelial Cell Therapy for Corneal Endothelial Cell Dysfunction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Corneal Endothelial Cell Dysfunction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. Eventually, they will reconstitute functional corneal endothelium to subside the corneal edema and improve the visual acuity.


Eligibility criteria: Inclusion Criteria:

-

Patient who's one eye or both eyes diagnosed with corneal endothelial cell dysfunction who met the following inclusion criteria were deemed eligible:

1. A BCVA of \< 0.5.
2. CECs could not be observed via specular microscopy or CEC density was \< 500 cells/mm2.
3. Corneal thickness \> 650 μm and the presence of corneal epithelial edema.
4. Patient age at the time of obtaining written consent was between 20 and 90 years.
5. 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.

Exclusion Criteria:

- Patients who met the following criteria parameters were deemed ineligible and were excluded from the study.

1. Patients with and active corneal infection (i.e., fungus, bacteria, virus. Etc.).
2. The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation.
3. The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months.
4. 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.
5. Patients with a hemorrhagic disease (In the patients who is taking Warfarin, the INR is over 3.0.).
6. 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.
7. 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.).
8. Patients with acute eye infection or inflammation (i.e., bacterial or fungal infection, acute uveitis.)
9. Diabetic patients with a poor blood-sugar control (Patients with HbA1c \> 10% within the past three months.).
10. Patients who were hypersensitive to steroids.
11. Patients with systemic autoimmune disease (i.e., systemic lupus erythematosus, Behcet's disease, etc.)
12. Patients strongly suspected to have a severe visual disorder due to concomitant other factors.
13. Patients who had already received this therapy.
14. Patients who had used or were planning to use an anti-cancer drug.
15. Patients with a past history of heart disease (i.e., myocardial infarction, heart failure, severe arrhythmia, etc.) or a cerebral vascular disorder.
16. 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.
17. Patients who are allergic to the drug or ingredients used in this trial.

Primary outcomes:
measure: CEC density
timeFrame: 24-weeks
Secondary outcomes:
measure: Corneal thickness
timeFrame: 24-weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: