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Letters to the Editor   |    
Autologous Cultured Chondrocytes: Adverse Events Reports
Eileen M. Budri, RN, MBA; Judy Audett, RN, MSN, MPH; David Levine, MD, MPH; Patricia Fraser, MD, MPH, MS
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The authors did not receive grants or outside funding in support of their research for or preparation of this work. One or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (Genzyme Corporation). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2006 Nov 01;88(11):2538-2538
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To The Editor:In their recent report "Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration" (2006;88:503-7), Wood et al. summarize data submitted largely by Genzyme to the Food and Drug Administration's Adverse Event Reporting System from 1996 to 2003 and conclude that passive safety surveillance has utility for a somatic cellular therapy. We wish to provide additional information about adverse event data collection and follow-up of Carticel-treated patients, the spectrum of patients receiving Carticel, and Carticel manufacturing that we believe will enrich the context from which the authors' conclusions were made.
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