A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease

C. Warren Olanow, Christopher G. Goetz, Jeffrey H. Kordower, A. Jon Stoessl, Vesna Sossi, Mitchell F. Brin, Kathleen M. Shannon, G. Michael Nauert, Daniel P. Perl, James Godbold, Thomas B. Freeman

Research output: Contribution to journalArticlepeer-review

1209 Scopus citations

Abstract

Thirty-four patients with advanced Parkinson's disease participated in a prospective 24-month double-blind, placebo-controlled trial of fetal nigral transplantation. Patients were randomized to receive bilateral transplantation with one or four donors per side or a placebo procedure. The primary end point was change between baseline and final visits in motor component of the Unified Parkinson's Disease Rating Scale in the practically defined off state. There was no significant overall treatment effect (p = 0.244). Patients in the placebo and one-donor groups deteriorated by 9.4 ± 4.25 and 3.5 ± 4.23 points, respectively, whereas those in the four-donor group improved by 0.72 ± 4.05 points. Pairwise comparisons were not significant, although the four-donor versus placebo groups yielded a p value of 0.096. Stratification based on disease severity showed a treatment effect in milder patients (p = 0.006). Striatal fluorodopa uptake was significantly increased after transplantation in both groups and robust survival of dopamine neurons was observed at postmortem examination. Fifty-six percent of transplanted patients developed dyskinesia that persisted after overnight withdrawal of dopaminergic medication ("off"-medication dyskinesia). Fetal nigral transplantation currently cannot be recommended as a therapy for PD based on these results.

Original languageEnglish (US)
Pages (from-to)403-414
Number of pages12
JournalAnnals of Neurology
Volume54
Issue number3
DOIs
StatePublished - Sep 1 2003
Externally publishedYes

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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