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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07418177
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • AMD - Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • HiPSC-RPE cells — BIOLOGICAL
    HiPSC-RPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure
  • Erlotinib (150 mg daily) — DRUG
    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.
  • Prednisone — DRUG
    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.

Study Details

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

Key Dates

Start date
Feb 10, 2026
Status verified
Oct 2025
Primary completion
Jun 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HiPSC-RPE cells
    Subretinal transplantation of HiPSC-RPE cells in experimental eye

Primary Outcome Measure

Number of subjects with adverse events [ Time Frame: Two years following transplantation ]

Central Contacts

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