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Spheramine is a novel cell therapy product developed for the treatment of advanced Parkinson's disease. It consists of cultured human retinal pigment epithelial (hRPE) cells attached to cross-linked porcine gelatin microcarriers. The therapy is administered by stereotactic implantation into the striatum, aiming to provide a more continuous delivery of levodopa, as hRPE cells naturally produce this dopamine precursor. Unlike other cell-based therapies, Spheramine does not require immunosuppression due to its design. Clinical studies included open-label and randomized controlled trials in patients with advanced Parkinson’s disease who were inadequately controlled by standard oral medications[1][3][5]. The drug was granted Orphan Drug and Fast Track designation by the FDA for this indication[5].
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