July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Visual function improvement of Human Fetal Retinal Pigment Epithelium Transplantation in Age-related Macular Degeneration Patients
Author Affiliations & Notes
  • Songtao Yuan
    Ophthalmology, The first affiliated hospital of Nanjing Medical University, Nanjing, China
  • Han Shen
    Ophthalmology, The first affiliated hospital of Nanjing Medical University, Nanjing, China
  • Wen Fan
    Ophthalmology, The first affiliated hospital of Nanjing Medical University, Nanjing, China
  • Footnotes
    Commercial Relationships   Songtao Yuan, None; Han Shen, None; Wen Fan, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 1175. doi:
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    • Get Citation

      Songtao Yuan, Han Shen, Wen Fan; Visual function improvement of Human Fetal Retinal Pigment Epithelium Transplantation in Age-related Macular Degeneration Patients. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1175.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The purpose of this study was to elevate the safety and efficacy of human fetal retinal pigment epithelium (hfRPE) cell suspension transplantation in AMD patients.

Methods : First, the characterization of xeno-free GMP-grade hfRPE cells were elucidated by RPE-specific function examination, genomic microarray and tumorigenicity test. Next, the safety and efficacy of hfRPE was demonstrated by injecting into sub-retinal spaces of MerTK-/- mice and NaIO3-inducedretinal degeneration primate model. Finally, a prospective single-arm exploratory clinical trial was conducted (ClinicalTrials.gov NCT02868424 and Chinese Clinical Trial Registry ChiCTR-OPC-15006757).

Results : In this study, we developed a protocol to culture xeno-free GMP-grade hfRPE cells that are well suited for clinical cell-based therapy. The safety and efficacy of hfRPE cell transplantation was demonstrated in MerTK-/- mice and NaIO3-induced retinal degeneration primate model. Finally, hfRPE cell suspensions were injected into sub-retinal spaces of five AMD patients. Three dosage cohorts were established, and transplantation safety was demonstrated, and improvements of best-corrected visual acuity (BCVA) were found in four patients during an 18-month follow-up period.

Conclusions : GMP-grade hfRPE suspension transplantation in treatment of AMD patients showed preliminary safety and potential efficacy.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

Safety and efficacy of hfRPE transplantation in MerTK-/-mice and retinal degeneration primate model.

Safety and efficacy of hfRPE transplantation in MerTK-/-mice and retinal degeneration primate model.

 

Preliminary safety and potential efficacy of hfRPE transplantation in AMD patients.

Preliminary safety and potential efficacy of hfRPE transplantation in AMD patients.

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