Award
NIH Reporter #11416856
Developing autologous iPSC-RPE based IND for AMD patients
Recipient
National Eye Institute (NEI), NIH
Award Amount
$1,548,029.00
Ceiling
$1,548,029.00
Awarded
October 04, 2023
Identifier
11416856
Award for developing autologous iPSC-RPE based IND for AMD patients, including production, safety, and efficacy testing of iPSC-RPE transplants, with FDA and IRB approvals and ongoing patient enrollment.
Description
This project involves the production of GLP-grade iPSC lines and RPE from AMD patients, preclinical safety assessment of iPSC-RPE transplants in immunocompromised animals, and preclinical efficacy testing of iPSC-RPE transplants using a surgical protocol in pigs. The IND for this study was approved by the FDA in December 2019, and the clinical protocol received IRB approval in March 2020. Patient enrollment is ongoing. The project also includes collaboration to develop a dual RPE–photoreceptor patch with proof-of-concept studies underway.