Regenerative medicine for treatment of corneal diseases

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250109003

Enrollment

Registered

2025-01-09

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs Endothelial Corneal Dystrophy (FECD) with corneal decompensation Fuchs Endothelial Corneal Dystrophy Corneal Decompensation Cultured Human Corneal Endothelial Cells Cell Therapy Endothelial Cell Injection Therapy Ophthalmology Regenerative Medicine

Interventions

Patients will undergo endothelial cell transplantation via injection of cultured human corneal endothelial cells (hCECs) into the anterior chamber. The suspension consists of hCECs at a concentration

Experimental Biological/Vaccine

hCEC injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older, 2.Patients diagnosed with Fuchs endothelial corneal dystrophy (FECD) with endothelial decompensation, presenting with clear clinical symptoms that affect vision. These include 2.1Best-corrected visual acuity (BCVA) worse than 20/40, 2.2 Corneal stromal edema. 2.3 Endothelial cell density (ECD) of fewer than 500 cells/mm2 or abnormal cell morphology.

Exclusion criteria

Exclusion criteria: 1.Patients with no light perception (NLP) in one or both eyes. 2.Patients with chronic systemic conditions that impair wound healing or require immunosuppressive medications. 3.Patients with immune deficiency disorders. 4.Patients unable to comply with follow-up visits. 5.Patients who are unable to lie face down for 3 hours postoperatively or are at risk of harm from prolonged prone positioning, as determined by the investigator.

Design outcomes

Primary

Measure	Time frame
Best-Corrected Visual Acuity (BCVA) 12 months logMAR,Corneal Thickness 12 months Ultrasound pachymetry,Endothelial Cell Density (ECD) 12 months Specular microscopy	—

Secondary

Measure	Time frame
Refractive Error 12 months Automated refractometry,Intraocular Pressure (IOP) 12 months Goldmann applanation tonometry,Visual Field 12 months Automated perimetry,Surgical complications within one year after surgery Assessed by clinical examination and review of patient symptoms	—

Countries

Thailand

Contacts

Public ContactVilavun Puangsricharern

Faculty of Medicine, Chulalongkorn University

vilavun@hotmail.com662564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026