Cell Therapy for Corneal Endothelial Cell Dysfunction
Taiwan12 participantsStarted 2025-04-25
Plain-language 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.
Who can participate
Age range20 Years â 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. A BCVA of \< 0.5.
â. CECs could not be observed via specular microscopy or CEC density was \< 500 cells/mm2.
â. Corneal edema with a corneal thickness \> 650 Ξm.
â. Patient age at the time of obtaining written consent was between 20 and 90 years.
â. 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
â. Patients with corneal infection (i.e., fungus, bacteria, virus. Etc.).
â. The treatment eye had been cataract surgery, pupilloplasty, or the vision or complication is not stabilized post-operation within one month before transplantation.
â. The treatment eye had received corneal transplantation, other eye surgeries, retinal laser, any kind of invasive eye treatment or drug injection within three months.
â. 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.
â. Patients with a hemorrhagic disease (In the patients who is taking Warfarin, the INR is over 3.0.).
â. 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.
â. 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.).
â. Patients with acute eye infection or inflammation (i.e., bacterial or fungal infection, acute uveitis.)