NCT07418177

Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD

Study in Human iPSCs-derived Retinal Pigment Epithelium Cells Transplantation for Late-Stage Age-Related Macular Degeneration

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase I Study of the Safety and Preliminary Efficacy of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial (HiPSC-RPE) Cells Subretinal Transplantation in Late-Stage Age-Related Macular Degeneration(AMD) Patients

Conditions

• AMD - Age-Related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	HiPSC-RPE cells	HiPSC-RPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure
DRUG	Erlotinib (150 mg daily)	Subjects began oral administration of erlotinib one day before surgery at a dose of 150 mg once daily for a total duration of 1 month.
DRUG	Prednisone	Prednisone was initiated 3 days prior to surgery at a dose of 30 mg/day (5 mg per tablet, 6 tablets daily) and continued for 6 weeks, with the dose tapered by one tablet per week until discontinuation.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-06-01
• Completion: 2028-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China