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Scientific Articles   |    
A Novel Process for Optimizing Musculoskeletal Allograft Tissue to Improve Safety, Ultrastructural Properties, and Cell Infiltration
Patrick W. Whitlock, MD, PhD1; Thorsten M. Seyler, MD1; Griffith D. Parks, PhD1; David A. Ornelles, PhD1; Thomas L. Smith, PhD1; Mark E. Van Dyke, PhD1; Gary G. Poehling, MD1
1 Department of Orthopaedic Surgery (P.W.W., T.M.S., T.L.S., and G.G.P.), Department of Microbiology and Immunology (G.D.P. and D.A.O.), and Institute for Regenerative Medicine (M.E.V.D.), Wake Forest University Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157. E-mail address for P.W. Whitlock: pwhitloc@wfubmc.edu
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Investigation performed at the Department of Orthopaedic Surgery, Department of Microbiology and Immunology, and Institute for Regenerative Medicine, Wake Forest University Health Sciences, Winston-Salem, North Carolina

This article was chosen to appear electronically on July 11, 2012, in advance of publication in a regularly scheduled issue.



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Aug 15;94(16):1458-1467. doi: 10.2106/JBJS.K.01397
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Abstract

Background: 

This study evaluated the properties of scaffold derived from freeze-dried human Achilles tendon allograft for use in anterior cruciate ligament (ACL) reconstruction. Our hypothesis was that such an allograft could be processed using a method to remove cellular and infectious material, producing a cytocompatible, architecturally modified scaffold possessing tensile properties suitable for ACL reconstruction.

Methods: 

Fifty-two allografts were provided by a tissue bank. Twenty-one were used as controls to assess cellularity, DNA content, microarchitecture, porosity, cytocompatibility, and tensile properties in vitro (n = 13) and in vivo (n = 8). Thirty-one were processed to produce scaffolds that were similarly assessed for these properties in vitro (n = 23) and in vivo (n = 8). The elimination of added enveloped and nonenveloped viruses was also determined in vitro after each processing step.

Results: 

A subjective decrease in cellularity and a significant decrease in DNA content were observed in the scaffolds compared with the allografts from which they had been derived. The porosity was increased significantly, and the scaffolds were cytocompatible in vitro. Processing resulted in significantly increased elongation of the scaffolds (138% of the elongation of the unprocessed allograft) during tensile testing. No other significant differences in tensile properties were observed in vitro or in vivo. The number of infiltrating host cells and the depth to which those cells infiltrated were significantly greater in the scaffolds. No enveloped viruses and only two of 108 nonenveloped viruses were detected in the scaffolds after processing, corresponding to a sterility assurance level of 0.2 × 10−7.

Conclusions: 

Allografts were processed using a method that removed cellular and infectious material to produce a decellularized, cytocompatible, architecturally modified scaffold with tensile properties that differed minimally from those of human allograft tissue both in vitro and in vivo. The scaffold production process also resulted in an increase in porosity that led to increased cell infiltration in vivo.

Clinical Relevance: 

Scaffolds derived from such tendon allografts have the potential to eliminate disease transmission and inflammation in recipients and to promote earlier and increased cell infiltration while retaining the initial tensile properties necessary to withstand rehabilitation after implantation.

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    Topics

    allografting
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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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