The National Institute of Neurological Disorders and Stroke(NINDS) is funding the first federal grant for fetal tissuetransplantation research since President Clinton overturned theban on such research in January 1993.
The double-blind, controlled trial will involve 40 patients withParkinson's disease. They will initially be evaluated andrandomized to one of two treatment arms by Stanley Fahn atColumbia University. He will record their motor ability onvideotape and measure the amount of metabolically activetissue (i.e., dopamine-producing cells) in their brains. Thepatients will then be sent to the University of Colorado fortreatment by NINDS grantee Curt Freed. Dopamine-producingfetal tissue will be transplanted into the brains of half thepatients; the other half will undergo sham surgery. They willthen return to Columbia University for post-operativeevaluation.
The grant has sparked some controversy in the researchcommunity for focusing on one transplantation procedure andfor using sham surgery on a control group. The Network ofEuropean CNS Transplantation and Restoration (NECTAR) wrotea letter criticizing the grant for assessing only one neuraltransplantation procedure at a single center. The letter will bepublished in the Feb. 11 issue of Science.
NECTAR was formed in 1990 by European researchers withexperience in experimental and clinical neural transplantation.
"Since transplantation techniques are still at an early stage ofdevelopment, the optimal methods of tissue procurement, graftpreparation, and implantation are not yet established," theletter said. "Consequently the results and implications of anysingle trial must be considered with great caution." NECTARsaid it is concerned that the single trial funded by NINDS maybe viewed as "the critical test of the therapeutic value of neuraltransplantation."
NINDS acting director, Patricia Grady, said the Freed study isthe first of several applications the institute expects to receive.She said NINDS did not put out a request for applications sinceFreed's application was pending at the institute when Clintonoverturned the ban on federally funded fetal-tissue research.The National Heart, Lung and Blood Institute and the NationalInstitute of Diabetes and Digestive and Kidney Diseases also arereportedly funding fetal tissue research.
With regard to the sham procedure, Grady said this is the firsttime this type of trial has been done in patients withParkinson's disease. She said the procedure is intended to"dissect out the treatment effect" of the fetal tissuetransplantation. Three institutional review boards -- at theUniversity of Colorado, Columbia University and NorthshoreHospital, which is affiliated with Cornell University -- approvedthe experiment.
-- Brenda Sandburg News Editor
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