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From: E-MOVE <[log in to unmask]> To: E-MOVE <[log in to unmask]> Subject: No Symptomatic Benefit in Second Fetal Transplant Double-Blind Trial (MovDis Congress 2002) Date sent: Fri, 15 Nov 2002 06:41:13 GMT E-MOVE reports from the Seventh International Congress of Parkinson’s Disease and Movement Disorders, November 10-14 in Miami, Florida. Poster (P) and page numbers are from Movement Disorders 2002;17(suppl 5). Transplantation of fetal tissue does not improve parkinsonian disability, and can cause off-medication dyskinesias, according to results from a new double-blind study presented in a platform session. The lack of symptomatic benefit occurred despite significant improvements seen with PET imaging. Thirty-four patients were randomized to receive bilateral grafting of 4 fetal tissues per side, 1 tissue per side, or sham surgery (partial burr hole without penetration of the dura), similar to the previous double-blind surgical trial by Freed et al. Unlike that trial, tissues were held for less than 48 hours before transplantation, and all patients received immunosuppression for six months after surgery. Other differences included the number of tissues used (4 or 1 vs. 2), the target site (posterior putamen vs. caudate and putamen), trial duration (24 vs. 12 months), and primary outcome variable (UPDRS motor score vs. quality of life). Fluorodopa uptake was assessed via PET imaging in a subset of patients. Thirty-one patients completed the trial. Two patients died during the trial, and 3 afterward, for causes unrelated to the procedure. Post-mortem examination was performed on all patients. While placebo patients showed virtually no tyrosine hydroxylase staining in the striatum, transplanted patients did, indicating striatal innervation. In patients with 4 tissues "the surrounding striatum was very well innervated," according to Dr. Warren Olanow, who presented the results. PET results indicated a significant dose-dependent increase versus baseline in fluorodopa uptake, with no change in placebo patients and an approximate one-third increase in patients receiving 4 tissues. Despite these histochemical and imaging improvements, no significant differences were seen in clinical measures. Increase (worsening) from baseline in the UPDRS motor score while off medication was 9.4 for placebo, 3.5 for 1 tissue, and -0.72 for 4 tissues (p=0.096 for 4 vs placebo). Dr. Olanow noted results for treated patients improved for approximately 9 months, then worsened, possibly suggesting a delayed immune response. No differences were seen for on time without dyskinesias, total off time, ADL scores, or levodopa dose required. Patients with initially lower UPDRS scores did respond significantly better to treatment than to placebo, while those with higher scores did not. No placebo patients, but 13 of 23 treated patients, developed off-medication dyskinesias, similar in kind to those seen in the Freed trial. Three patients required surgical treatment to control them. "Despite the hope and promise of open label trials, fetal translation in our study failed to meet its primary or secondary endpoints," Dr. Olanow concluded. ---- 2002 E-MOVE conference reports are made possible in part through unrestricted educational grants from Bertek Pharmaceuticals, Elan Pharmaceuticals, GlaxoSmithKline, Pharmacia Corporation, and Procter & Gamble Pharmaceuticals. Editor: Richard Robinson ( [log in to unmask] ) - Your E-MOVE news subscription is provided free of charge, courtesy of WE MOVE. PRIVATE DONATIONS ARE NEEDED TO SUPPORT WE MOVE's VALUABLE, FREE SERVICES LIKE THIS ELECTRONIC NEWS SERVICE. Donate online at http://www.wemove.org, or send your tax-deductible contribution to WE MOVE, 204 West 84th Street New York, NY 10024. TEL 800-437-MOV2 or 212- 875-8312. Thank you so much! - This document may be freely redistributed by email only in its unedited form. We encourage you to share it with your colleagues. Visit http://www.wemove.org/emove for E-MOVE archives and information on subscribing to E-MOVE. To unsubscribe, visit http://www.wemove.org/emove/unsubscribe.asp - WE MOVE 204 West 84th Street New York, NY 10024 TEL 800-437-MOV2 TEL 212-875-8312 FAX 212-875-8389 * * * Not at all good news... murray * * * Murray Charters <[log in to unmask]> http://www.geocities.com/murraycharters/ ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn