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

  1. C. Warren Olanow MD1,*,
  2. Christopher G. Goetz MD2,
  3. Jeffrey H. Kordower PhD2,
  4. A. Jon Stoessl MD3,
  5. Vesna Sossi PhD3,
  6. Mitchell F. Brin MD1,
  7. Kathleen M. Shannon MD2,
  8. G. Michael Nauert MD4,
  9. Daniel P. Perl MD5,
  10. James Godbold PhD6,
  11. Thomas B. Freeman MD4

Article first published online: 28 AUG 2003

DOI: 10.1002/ana.10720

Issue

Annals of Neurology

Annals of Neurology

Volume 54, Issue 3, pages 403–414, September 2003

Additional Information

How to Cite

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. and Freeman, T. B. (2003), A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease. Annals of Neurology, 54: 403–414. doi: 10.1002/ana.10720

Author Information

  1. 1

    Department of Neurology, Mount Sinai School of Medicine, New York, NY

  2. 2

    Department of Neurological Sciences, Rush Presbyterian Medical Center, Chicago, IL

  3. 3

    Pacific Parkinson's Research Centre, University of British Columbia, Vancouver, British Columbia, Canada

  4. 4

    Department of Neurosurgery, University of South Florida, Tampa, FL

  5. 5

    Department of Pathology, Mount Sinai School of Medicine, New York, NY

  6. 6

    Department of Community and Preventive Medicine, Mount Sinai School of Medicine, New York, NY

*Department of Neurology, Box 1137, Mount Sinai School of Medicine, One Gustave L. Levy Place, New York, NY 10029

  1. †

    For a list of contributors to this study, see the ‡ on page 413.

Publication History

  1. Issue published online: 28 AUG 2003
  2. Article first published online: 28 AUG 2003
  3. Manuscript Revised: 15 JUL 2003
  4. Manuscript Accepted: 15 JUL 2003
  5. Manuscript Received: 19 JUN 2003

Funded by

  • National Institutes of Health. Grant Number: NS32842
  • Bendheim Parkinson's Disease Center
  • Bachman Strauss Dystonia and Parkinson Foundation

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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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