First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency

First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency - First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTa050190084

Enrollment

Registered

2019-12-18

Start date

2019-06-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

limbal stem-cell deficiency

Interventions

Transplantation of iPS derived corneal epithelial cell sheet (iCEPS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Limbal stem-cell deficiency patients who have been classified as LSCD Stage IIB, IIC, or III 2) Aged 20 years old and over, and written informed consent has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1) Contraindication to antimicrobials, steroid drugs, and anesthetics used in the trial 2) Allergy to antibiotics of penicillin, streptomycin, or animal (cattle, pigs, or rodent animal) 3) Test positive for Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus

Design outcomes

Primary

Measure	Time frame
Safety(Adverse events)	—

Secondary

Measure	Time frame
Efficacy 1) LSCD staging, 2) corneal epithelial defect, 3) subjective symptom, 4) visual acuity, 5) QOL, 6) corneal opacity, 7) corneal neovascularization, 8) symblepharon	—

Countries

Japan

Contacts

Public ContactTakeshi Soma

Osaka University Graduate School of Medicine

ips_cornea@ophthal.med.osaka-u.ac.jp+81-6-6879-3451

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026