Updated on 1 August 2013
Transplant sites will be monitored closely for functional integration and potential adverse reactions for an initial intensive observation period of one year, and subsequent follow-up observation for three years. Production and validation of the autologous iPSCs and subsequent RPE cell sheets will take approximately 10 months, and will be conducted at a certified clinical-grade cell processing center. The initial three transplants will be conducted at intervals of at least eight weeks; the following three will be performed after a preliminary safety evaluation period.
This pilot study follows on extensive preclinical safety and feasibility testing, including evaluations of cell morphology, physiologic activity, gene expression, immunogenicity, and tumorigenesis in rodent and non-human primate models.