Retinitis Pigmentosa. Clinical Trial
Official title:
Safety Study in Retinal Transplantation for Retinitis Pigmentosa.
The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.
The aim of this clinical trial is to test the safety of transplanting human fetal neural
retinal tissue and retinal pigment epithelium into the eyes of human patients with retinitis
pigmentosa. Vision in the eye to be operated on will be the poorer vision of both eyes and
must be 20/200 or worse. "Retinal tissue", the layers in the back of the eye, consists of
neural retina and retinal pigment epithelium. "Neural retina" is the nerve cell layer that
processes light into vision. The "photoreceptor cells" in the neural retina detect the light
and transform it into electrical signals, which are then transferred to the brain by other
retinal cells. "Retinal pigment epithelium" (RPE) is the layer behind the neural retina which
helps both to nourish the cells of the neural retina and also to get rid of waste products.
The fetal tissues used in this study will be derived from dead fetuses in the first 9-16
weeks of pregnancy obtained from elective abortions.
Fetal retinal transplantation is highly experimental. The research will be conducted in
accordance with the prohibitions regarding the use of human fetal tissue described in Public
Law 103-43, section 498B. There will be no compensation for the donor. The research will be
conducted in accordance with any applicable Federal, State and local laws.
First, the technical application of the implantation instrument and its safety in the
transplantation will be demonstrated in patients with 20/200 vision in one eye or worse, with
functional acuity in the contra lateral eye.
Secondly, the human fetal retinal tissue will be placed in the areas beneath the retina where
presently the patient has atrophy of the retinal pigment epithelium and poor retinal
function.
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