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Implanted retinal pigmented epithelial cells are not effective for treatment of advancing Parkinson's disease, according to a new double-blind trial. The cells (trade name Spheramine®) are embedded in a support matrix, and release dopamine. These results contradict those from a small, open-label trial, reported previously by E-MOVE. www.mdvu.org/emove/article.asp?ID=436 Seventy-one patients were randomized to receive placebo or cell implantation bilaterally into the putamen. Patients were ages 36-70, with PD of at least 5 years' duration and with symptoms inadequately controlled by medications. Sham-operated patients received partial burr holes but without dural penetration. The primary endpoint was change in UPDRS III (motor) off score at 12 months. OFF ON baseline 12 months baseline 12 months Spheramine 48.8 38.3 18.4 19.7 sham 48.8 38.7 18.1 17.8 There was no statistically significant difference between Spheramine- and sham-implanted patients at 12 months in the off state. There were also no differences in secondary outcomes, including on-state UPDRS III, time spent in off or on state, levodopa reduction, or UPDRS ADL score. "The study failed to show efficacy of cellular implants of human retinal pigmented epithelial cells beyond a remarkable placebo effect," the authors concluded. "Preliminary long-term results in part of the study patients suggests that the placebo effect persists even longer than 12 months." This study was presented at a conference. These data and conclusions should be considered to be preliminary until they are reviewed and published in a peer- reviewed publication. The STEPS trial: A Phase 2b study evaluating Spheramine® in patients with advanced Parkinson's disease RL Watts, RE Gross, RA Hauser, RAE Bakay, H Reichmann, Weisner, NP Stover, E Reissig, H Steiner-Schulze, K Fichte LB-18 ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn