The long tend objectives of this collaborative STTR research project are to refine, test, and then bring to market an instrument and procedures for use by ophthalmologists to transplant neural retina and retinal pigment epithelium (RPE) into the eyes of patients blinded by retinitis pigmentosa, retinal dystrophies, and macular degeneration in order to improve visual function. Studies by this group have shown that the co-transplantation of embryonic retina with RPE, as intact flat sheets, has the greatest potential for graft development, for long term survival of ordered retinal tissue, and for the restoration of visual function. These tiny sheets are extremely fragile and easily roll up, making the method of dissection and implantation critical to the preservation of the integrity of RPE-neural retina interactions and to the success of the transplant. Specially designed procedures and instruments are needed to protect the intact sheets during dissection and transplantation. During phase I, we plan to conduct laboratory studies in which we will further develop and refine (l) a prototype tool for transplanting intact sheets of retina with RPE into the subretinal space together with (2) a protocol for dissecting, and embedding the cograft sheets in a protective gel wafer. During phase II, these will be further tested and refined for eventual use in patients, based on the feasibility results from phase I. PROPOSED COMMERCIAL APPLICATIONS: This product will provide to clinicians a means of transplanting healthy retinal tissue into the eyes of patients with retinal disease such as retinitis pigmentosa, retinal dystrophies, and macular degeneration. The potential USA market for the surgical instruments includes 1,800 retinal surgeons and the potential market for the protocol for dissecting and preserving co- graft of neural retina with RPE includes more than three million patients who will be eligible for this surgery, as well as numerous U.S. research laboratories conducting transplantation research, plus the respective world- wide markets
