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A double‐blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease
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;54:403–414
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“Data from one of the two randomized clinical trials suggested a potential decline in clinical function after discontinuation of immunosuppression25, yet autopsy reports in other studies demonstrated graft survival many years after surgery and discontinuation of immunosuppression.”
From Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease (2025) · cites this paper as [25]
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“In past fetal allograft studies, the dosing, duration and type of immunosuppression was inconsistent.25,26,45.”
From Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease (2025) · cites this paper as [25]
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“A high incidence of GID was reported in two randomized controlled trials25,26 of fetal ventral mesencephalic transplants (56% (n = 13 out of 23) and 15% (n = 5 out of 33) of grafted participants).”
From Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease (2025) · cites this paper as [25]
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“This method had been previously validated49,50 and used successfully in the PET imaging studies of fetal cell transplantation25,42,51,52.”
From Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease (2025) · cites this paper as [25]
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Metadata
- Authors
- Olanow, C. W., Goetz, C. G., Kordower, J. H., Stoessl, A. J., Sossi, V., Brin, M. F., Shannon, K. M., Nauert, G. M., Perl, D. P., Godbold, J., & Freeman, T. B.
- Venue
- Annals of Neurology
- Publisher
- Wiley
- Published
- 2003-08-28
- Volume
- 54
- Issue
- 3
- Pages
- 403-414
- ISSN
- 0364-5134
- 1531-8249
- Cited by
- 1,307
- References
- 0
- Language
- en
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