A double‐blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease
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- 28 August 2003
- journal article
- clinical trial
- Published by Wiley in Annals of Neurology
- Vol. 54 (3) , 403-414
- https://doi.org/10.1002/ana.10720
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.Ann Neurol 2003;54:403–414Keywords
This publication has 36 references indexed in Scilit:
- Dyskinesia after fetal cell transplantation for parkinsonism: A PET studyAnnals of Neurology, 2002
- Dyskinesias following neural transplantation in Parkinson's diseaseNature Neuroscience, 2002
- Use of Placebo Surgery in Controlled Trials of a Cellular-Based Therapy for Parkinson's DiseaseNew England Journal of Medicine, 1999
- Functional fetal nigral grafts in a patient with Parkinson's disease: Chemoanatomic, ultrastructural, and metabolic studiesJournal of Comparative Neurology, 1996
- Fetal nigral transplantation as a therapy for Parkinson's diseaseTrends in Neurosciences, 1996
- Bilateral fetal nigral transplantation into the postcommissural putamen in Parkinson's diseaseAnnals of Neurology, 1995
- The influence of donor age on the survival of solid and suspension intraparenchymal human embryonic nigral graftsCell Transplantation, 1995
- Bilateral motor improvement and alteration of L-dopa effect in two patients with Parkinson's disease following intrastriatal transplantation of foetal ventral mesencephalonBrain, 1994
- Core assessment program for intracerebral transplantations (CAPIT)Movement Disorders, 1992
- FETAL NEURONAL GRAFTS IN MONKEYS GIVEN METHYLPHENYLTETRAHYDROPYRIDINEThe Lancet, 1986