The Journal of Bone and Joint Surgery (American). 2006;88:503-507.
doi:10.2106/JBJS.E.00103
© 2006 The Journal of Bone and Joint Surgery, Inc.
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow [Supplementary Material]
Right arrow Letters to the Editor: Submit a response
Right arrow Letters to the Editor: View responses
Right arrow Alert me when this article is cited
Right arrow Alert me when Letters to the Editor are posted
Right arrow Alert me if a correction is posted
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrowReprints and Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Wood, J. J.
Right arrow Articles by Coté, T. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Wood, J. J.
Right arrow Articles by Coté, T. R.
Related Collections
Right arrow Basic Science
Right arrow Adult Knee
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Technorati  
What's this?

Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration

Jennifer J. Wood, PhD, MPH1, Mark A. Malek, MD, MPH2, Frank J. Frassica, MD5, Jacquelyn A. Polder, BSN, MPH2, Aparna K. Mohan, MD, PhD3, Eda T. Bloom, PhD4, M. Miles Braun, MD, MPH4 and Timothy R. Coté, MD, MPH2

1 11631 S.W. 2nd Street, Pembroke Pines, FL 33025
2 Centers for Disease Control, MS-A34 (M.A.M.), MS-E08 (J.A.P.), and MS-G25 (T.R.C.), Atlanta GA 30329-4018
3 2045 Silverwood Drive, Newtown, PA 18940
4 Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852. E-mail address for M.M. Braun: braunm{at}cber.fda.gov
5 Johns Hopkins University, 601 North Caroline Street, Baltimore, MD 21287

Investigation performed at the Center for Biologics Evaluations and Research, Food and Drug Administration, Rockville, Maryland

NOTE: The authors thank Dr. Susan Leibenhaut for her contribution in the critical revision of the manuscript.

The authors did not receive grants or outside funding in support of their research for or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. 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.

Background: Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures. The present report describes the adverse events following Carticel implantation as reported to the Food and Drug Administration from 1996 to 2003.

Methods: We reviewed adverse event reports that had been submitted to the Food and Drug Administration's MedWatch system for information on demographic characteristics, adverse events, and surgical revisions. Adverse events were categorized into sixteen non-mutually exclusive groups. Five categories were used to classify reoperations. Food and Drug Administration regulations require manufacturers to report adverse events; however, reporting by clinicians and others is voluntary. Therefore, adverse event reporting is likely to underestimate the number of event occurrences. Adverse events may be either causally or coincidentally related to the product.

Results: A total of 497 adverse events among 294 patients receiving Carticel were reported. The median interval from Carticel implantation to the diagnosis of an adverse event was 240 days (range, one to 2105 days). The median age of the patients was thirty-eight years, and 63% of the patients were male. Of the 270 events for which the anatomic site was noted, 258 (96%) involved the femoral condyles. More than one adverse event was reported for 135 patients (46%). The most commonly reported events were graft failure (seventy-three patients; 25%), delamination (sixty-five patients; 22%), and tissue hypertrophy (fifty-two patients; 18%). In addition, eighteen surgical site infections were reported, including eleven joint and seven soft-tissue infections. Surgical revision subsequent to Carticel implantation was mentioned in the records for 273 patients (93%). The reasons for the 389 revision procedures included graft-related problems (187 procedures; 48.1%), periarticular soft-tissue problems (ninety-seven procedures; 24.9%), and intra-articular problems (sixty-three procedures; 16.2%). Eight patients had a total knee replacement. Based on the manufacturer's reported distribution of 7500 Carticel lots between 1995 and 2002, 285 patients (3.8%) had an adverse event that was reported to the Food and Drug Administration.

Conclusions: The most common adverse events reported in association with the Carticel technique involved graft failure, delamination, and tissue hypertrophy.

Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Technorati Technorati    What's this?


This article has been cited by other articles:


Home page
 Am J Sports MedHome page
A. G. McNickle, D. R. L'Heureux, A. B. Yanke, and B. J. Cole
Outcomes of Autologous Chondrocyte Implantation in a Diverse Patient Population
Am. J. Sports Med., July 1, 2009; 37(7): 1344 - 1350.
[Abstract] [Full Text] [PDF]

Home page
 Am J Sports MedHome page
E. K. Nam, R. D. Ferkel, and G. R. Applegate
Autologous Chondrocyte Implantation of the Ankle: A 2- to 5-Year Follow-Up
Am. J. Sports Med., February 1, 2009; 37(2): 274 - 284.
[Abstract] [Full Text] [PDF]

Home page
 Am J Sports MedHome page
P. Niemeyer, J. M. Pestka, P. C. Kreuz, C. Erggelet, H. Schmal, N. P. Suedkamp, and M. Steinwachs
Characteristic Complications After Autologous Chondrocyte Implantation for Cartilage Defects of the Knee Joint
Am. J. Sports Med., November 1, 2008; 36(11): 2091 - 2099.
[Abstract] [Full Text] [PDF]

Home page
 Am J Sports MedHome page
H. S. Vasiliadis, M. Doukas, A. Batistatou, A. Georgoulis, and A. E. Beris
Chondromatosis of the Knee Joint 8 Months After Autologous Chondrocyte Implantation
Am. J. Sports Med., October 1, 2008; 36(10): 2023 - 2027.
[Full Text] [PDF]

Home page
 J. Med. EthicsHome page
L Trommelmans, J Selling, and K Dierickx
Ethical reflections on clinical trials with human tissue engineered products
J. Med. Ethics, September 1, 2008; 34(9): e1 - e1.
[Abstract] [Full Text] [PDF]

Home page
 J. Histochem. Cytochem.Home page
A. J. Hayes, A. Hall, L. Brown, R. Tubo, and B. Caterson
Macromolecular Organization and In Vitro Growth Characteristics of Scaffold-free Neocartilage Grafts
J. Histochem. Cytochem., August 1, 2007; 55(8): 853 - 866.
[Abstract] [Full Text] [PDF]

Home page
 RadioGraphicsHome page
Y. Y. Ho, A. J. Stanley, J. H.-P. Hui, and S.-C. Wang
Postoperative Evaluation of the Knee after Autologous Chondrocyte Implantation: What Radiologists Need to Know
RadioGraphics, January 1, 2007; 27(1): 207 - 220.
[Abstract] [Full Text] [PDF]

Letters to the Editor:

Read all Letters to the Editor

Carticel Adverse Events Reports
Eileen M. Budri, RN, MBA, et al.
JBJS Online, 25 May 2006 [Full text]
Autologous Cultured Chondrocytes: Adverse Events Reported To The United States Food And Drug Adminis
Chris R. Gooding, MRCS, et al.
JBJS Online, 25 May 2006 [Full text]
Dr. Braun et al respond to Drs. Budri et al and Gooding et al
M. Miles Braun, M.D., MPH, et al.
JBJS Online, 25 May 2006 [Full text]