Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2019
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
_version_ 1783384133958893568
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
work_keys_str_mv AT chuconstancer optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT rodeoscott optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT bhutaninidhi optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT goodrichlaurier optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT huardjohnny optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT irrgangjames optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT lapraderobertf optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT lattermannchristian optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT luying optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT mandelbaumbert optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT maojeremy optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT mcintyrelouis optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT mishraallan optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT muschlergeorgef optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT piuzzinicolass optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT potterhollis optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT spindlerkurt optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT tokishjohnm optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT tuanrocky optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT zaslavkenneth optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference
AT maloneywilliam optimizingclinicaluseofbiologicsinorthopaedicsurgeryconsensusrecommendationsfromthe2018aaosnihu13conference