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Tests treatment safety and results for Cornea Disease
Official title A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction
ClinicalTrials.gov ID: NCT07435142
What this study is testing
What is Autologous urinary-derived epithelial cell injection?
Autologous urinary-derived epithelial cell injection is an investigational medicine, being studied as a potential treatment for cornea disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Corneal endothelial cell dysfunction is usually a corneal disease caused by damage or loss of corneal endothelial cells. It is characterized by corneal edema, opacity, and subepithelial bullae, leading to pain, blurred vision, or even blindness.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients diagnosed with corneal endothelial cell dysfunction, including those with a history of at least one penetrating keratoplasty.
- Patients aged 18 years or older and 85 years or younger at the time of informed consent acquisition (regardless of gender).
- Patients with central corneal endothelial cell density below 500-800 cells/mm² or unmeasurable, as detected by corneal endothelial microscopy or...
- Patients who can voluntarily participate in the study and provide written informed consent.
You likely can't join if
- Patients with unexplained keratoconjunctival diseases.
- Patients with active corneal infections or systemic infections (e.g., positive for bacteria, fungi, HBV, HCV, or other viruses).
- Patients with an intraocular pressure (IOP) of ≥30 mmHg (excluding those whose IOP can be controlled below 21 mmHg with glaucoma medications).
- Patients with neovascularization observed in the angle of the anterior chamber or who have undergone treatment for neovascular glaucoma.
- Patients with a history of allergies to drugs prescribed during the perioperative period and postoperative observation period [anesthetics (lidocaine...
- Patients planning to undergo intraocular surgery during this clinical study.
See the full eligibility criteria
- Patients diagnosed with corneal endothelial cell dysfunction, including those with a history of at least one penetrating keratoplasty.
- Patients aged 18 years or older and 85 years or younger at the time of informed consent acquisition (regardless of gender).
- Patients with central corneal endothelial cell density below 500-800 cells/mm² or unmeasurable, as detected by corneal endothelial microscopy or confocal microscopy.
- Patients who can voluntarily participate in the study and provide written informed consent.
- Patients with unexplained keratoconjunctival diseases.
- Patients with active corneal infections or systemic infections (e.g., positive for bacteria, fungi, HBV, HCV, or other viruses).
- Patients with an intraocular pressure (IOP) of ≥30 mmHg (excluding those whose IOP can be controlled below 21 mmHg with glaucoma medications).
- Patients with neovascularization observed in the angle of the anterior chamber or who have undergone treatment for neovascular glaucoma.
- Patients with a history of allergies to drugs prescribed during the perioperative period and postoperative observation period [anesthetics (lidocaine injection), antibiotics (ofloxacin eye drops or ointment), steroid...
- Patients planning to undergo intraocular surgery during this clinical study.
- Diabetic patients with poor blood glucose control (HbA1C ≥8.5%).
- Patients with a history of cancer or/and with systemic autoimmune disease.
- Patients with severe liver dysfunction (AST\>100 IU/L or ALT\>100 IU/L).
- Patients with severe renal dysfunction requiring dialysis (serum creatinine ≥1.5 mg/dl).
- Patients with a systolic blood pressure of ≥180 mmHg or diastolic blood pressure of ≥110 mmHg despite antihypertensive treatment.
- Pregnant women, women possibly pregnant, or women planning pregnancy during this clinical study period.
- Patients unable to tolerate ophthalmic surgery under local anesthesia (e.g., severe claustrophobia).
- Patients who participated in other clinical trials or studies within 3 month prior to consent acquisition.
- Patients deemed unsuitable for this clinical study due to comorbidities, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.