June 24-25, 2013
Identify potential road-blocks in developing cell-based therapies for retinal degenerative diseases. Participants included academicians, regulatory and ethics experts, and companies. Collaboration and harmonization of regulatory policies internationally were discussed. Topics included ethical concerns with tissue sourcing, manufacturing the cells, device and scaffold construction for transplantation, pre-clinical animal testing, patient selection criteria, design of clinical trials, and outcome variables. As part of the NIH mandate to stimulate collaborations and provide open access to new technology, NEI and the NIH Center for Regenerative Medicine (CRM) will provide community access to clinical-grade master cell banks, drug master files, and clinical protocols.