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Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference
Concern that misinformation from direct-to-consumer marketing of largely unproven “biologic” treatments such as platelet-rich plasma and cell-based therapies may erode the public trust and the responsible investment needed to bring legitimate biological therapies to patients have resulted in calls t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6314629/ https://www.ncbi.nlm.nih.gov/pubmed/30300216 http://dx.doi.org/10.5435/JAAOS-D-18-00305 |
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author | Chu, Constance R. Rodeo, Scott Bhutani, Nidhi Goodrich, Laurie R. Huard, Johnny Irrgang, James LaPrade, Robert F. Lattermann, Christian Lu, Ying Mandelbaum, Bert Mao, Jeremy McIntyre, Louis Mishra, Allan Muschler, George F. Piuzzi, Nicolas S. Potter, Hollis Spindler, Kurt Tokish, John M. Tuan, Rocky Zaslav, Kenneth Maloney, William |
author_facet | Chu, Constance R. Rodeo, Scott Bhutani, Nidhi Goodrich, Laurie R. Huard, Johnny Irrgang, James LaPrade, Robert F. Lattermann, Christian Lu, Ying Mandelbaum, Bert Mao, Jeremy McIntyre, Louis Mishra, Allan Muschler, George F. Piuzzi, Nicolas S. Potter, Hollis Spindler, Kurt Tokish, John M. Tuan, Rocky Zaslav, Kenneth Maloney, William |
author_sort | Chu, Constance R. |
collection | PubMed |
description | Concern that misinformation from direct-to-consumer marketing of largely unproven “biologic” treatments such as platelet-rich plasma and cell-based therapies may erode the public trust and the responsible investment needed to bring legitimate biological therapies to patients have resulted in calls to action from professional organizations and governing bodies. In response to substantial patient demand for biologic treatment of orthopaedic conditions, the American Academy of Orthopaedic Surgeons convened a collaborative symposium and established a consensus framework for improving and accelerating the clinical evaluation, use, and optimization of biologic therapies for musculoskeletal diseases. The economic and disease burden of musculoskeletal conditions is high. Of the various conditions discussed, knee osteoarthritis was identified as a “serious condition” associated with substantial and progressive morbidity and emerged as the condition with the most urgent need for clinical trial development. It was also recognized that stem cells have unique characteristics that are not met by minimally manipulated mixed cell preparations. The work group recommended that minimally manipulated cell products be referred to as cell therapy and that the untested and uncharacterized nature of these treatments be clearly communicated within the profession, to patients, and to the public. Minimum standards for product characterization and clinical research should also be followed. A framework for developing clinical trials related to knee OA was agreed upon. In addition to recommendations for development of high-quality multicenter clinical trials, another important recommendation was that physicians and institutions offering biologic therapies commit to establishing high-quality patient registries and biorepository-linked registries that can be used for postmarket surveillance and quality assessments. |
format | Online Article Text |
id | pubmed-6314629 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-63146292019-01-18 Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference Chu, Constance R. Rodeo, Scott Bhutani, Nidhi Goodrich, Laurie R. Huard, Johnny Irrgang, James LaPrade, Robert F. Lattermann, Christian Lu, Ying Mandelbaum, Bert Mao, Jeremy McIntyre, Louis Mishra, Allan Muschler, George F. Piuzzi, Nicolas S. Potter, Hollis Spindler, Kurt Tokish, John M. Tuan, Rocky Zaslav, Kenneth Maloney, William J Am Acad Orthop Surg Review Article Concern that misinformation from direct-to-consumer marketing of largely unproven “biologic” treatments such as platelet-rich plasma and cell-based therapies may erode the public trust and the responsible investment needed to bring legitimate biological therapies to patients have resulted in calls to action from professional organizations and governing bodies. In response to substantial patient demand for biologic treatment of orthopaedic conditions, the American Academy of Orthopaedic Surgeons convened a collaborative symposium and established a consensus framework for improving and accelerating the clinical evaluation, use, and optimization of biologic therapies for musculoskeletal diseases. The economic and disease burden of musculoskeletal conditions is high. Of the various conditions discussed, knee osteoarthritis was identified as a “serious condition” associated with substantial and progressive morbidity and emerged as the condition with the most urgent need for clinical trial development. It was also recognized that stem cells have unique characteristics that are not met by minimally manipulated mixed cell preparations. The work group recommended that minimally manipulated cell products be referred to as cell therapy and that the untested and uncharacterized nature of these treatments be clearly communicated within the profession, to patients, and to the public. Minimum standards for product characterization and clinical research should also be followed. A framework for developing clinical trials related to knee OA was agreed upon. In addition to recommendations for development of high-quality multicenter clinical trials, another important recommendation was that physicians and institutions offering biologic therapies commit to establishing high-quality patient registries and biorepository-linked registries that can be used for postmarket surveillance and quality assessments. Lippincott Williams & Wilkins 2019-01-15 2018-10-08 /pmc/articles/PMC6314629/ /pubmed/30300216 http://dx.doi.org/10.5435/JAAOS-D-18-00305 Text en Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Orthopaedic Surgeons. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Review Article Chu, Constance R. Rodeo, Scott Bhutani, Nidhi Goodrich, Laurie R. Huard, Johnny Irrgang, James LaPrade, Robert F. Lattermann, Christian Lu, Ying Mandelbaum, Bert Mao, Jeremy McIntyre, Louis Mishra, Allan Muschler, George F. Piuzzi, Nicolas S. Potter, Hollis Spindler, Kurt Tokish, John M. Tuan, Rocky Zaslav, Kenneth Maloney, William Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title | Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title_full | Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title_fullStr | Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title_full_unstemmed | Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title_short | Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference |
title_sort | optimizing clinical use of biologics in orthopaedic surgery: consensus recommendations from the 2018 aaos/nih u-13 conference |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6314629/ https://www.ncbi.nlm.nih.gov/pubmed/30300216 http://dx.doi.org/10.5435/JAAOS-D-18-00305 |
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