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Previous Volume 344:710-719 March 8, 2001 Number 10 Next

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ABSTRACT

Background Transplantation of human embryonic dopamine neurons into the brains of patients with Parkinson's disease has proved beneficial in open clinical trials. However, whether this intervention would be more effective than sham surgery in a controlled trial is not known.

Methods We randomly assigned 40 patients who were 34 to 75 years of age and had severe Parkinson's disease (mean duration, 14 years) to receive a transplant of nerve cells or undergo sham surgery; all were to be followed in a double-blind manner for one year. In the transplant recipients, cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally. In the patients who underwent sham surgery, holes were drilled in the skull but the dura was not penetrated. The primary outcome was a subjective global rating of the change in the severity of disease, scored on a scale of –3.0 to 3.0 at one year, with negative scores indicating a worsening of symptoms and positive scores an improvement.

Results The mean (±SD) scores on the global rating scale for improvement or deterioration at one year were 0.0±2.1 in the transplantation group and –0.4± 1.7 in the sham-surgery group. Among younger patients (60 years old or younger), standardized tests of Parkinson's disease revealed significant improvement in the transplantation group as compared with the sham-surgery group when patients were tested in the morning before receiving medication (P=0.01 for scores on the Unified Parkinson's Disease Rating Scale; P=0.006 for the Schwab and England score). There was no significant improvement in older patients in the transplantation group. Fiber outgrowth from the transplanted neurons was detected in 17 of the 20 patients in the transplantation group, as indicated by an increase in ¹⁸F-fluorodopa uptake on positron-emission tomography or postmortem examination. After improvement in the first year, dystonia and dyskinesias recurred in 15 percent of the patients who received transplants, even after reduction or discontinuation of the dose of levodopa.

Conclusions Human embryonic dopamine-neuron transplants survive in patients with severe Parkinson's disease and result in some clinical benefit in younger but not in older patients.

Source Information

From the University of Colorado School of Medicine, Denver (C.R.F., R.E.B., S.C.); Columbia University College of Physicians and Surgeons, New York (P.E.G., W.-Y.T., R.K., S.D., H.W., S.F.); AT&T Shannon Laboratory, Florham Park, N.J. (W.D.); University of Pennsylvania Medical Center, Philadelphia (J.Q.T.); and North Shore University Hospital, Manhasset, N.Y. (D.E.).

Address reprint requests to Dr. Freed at the Division of Clinical Pharmacology, C-237, University of Colorado School of Medicine, 4200 E. Ninth Ave., Denver, CO 80262, or at curt.freed{at}uchsc.edu.

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