Cell Therapy for Corneal Endothelial Cell Dysfunction

NCT06726174 | Active Not Recruiting Phase 1

• 1 other identifier: 202304098MINB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Endothelial Cell Dysfunction

Outcome Measures

Primary Outcomes (1)

• CEC density

  \> 500 cells/mm2

  24-weeks

Secondary Outcomes (1)

• Corneal thickness

  24-weeks

Study Arms (1)

Cell

EXPERIMENTAL

Drug: ECCEC

Interventions

ECCEC DRUG

0.5-1x10\^6 cells/300 uL, intracameral injection.

Cell

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

TW (1)