Improved MSC Minimal Criteria to Maximize Patient Safety: A Call to Embrace Tissue Factor and Hemocompatibility Assessment of MSC Products
Abstract The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated “Stem Cell Clinics” offering diverse “Unproven Stem Cell Interventions.” This product diversification...
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| Vydáno v: | Stem cells translational medicine Ročník 11; číslo 1; s. 2 - 13 |
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| Hlavní autoři: | , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
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Oxford University Press
03.03.2022
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| Témata: | |
| ISSN: | 2157-6564, 2157-6580, 2157-6580 |
| On-line přístup: | Získat plný text |
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| Abstract | Abstract
The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated “Stem Cell Clinics” offering diverse “Unproven Stem Cell Interventions.” This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products.
Graphical Abstract
Graphical Abstract
A broad spectrum of oversight impacts on MSC product safety in patients. We here outline the necessary steps toward integration of highly procoagulant tissue factor (TF/CD142) and hemocompatibility assessment of diversified intravascular MSC products as a new safety criterion into the existing MSC minimal criteria. Regulatory authorities and international societies should undertake coordinated efforts to update the already established guidelines. |
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| AbstractList | The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated “Stem Cell Clinics” offering diverse “Unproven Stem Cell Interventions.” This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products. The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated "Stem Cell Clinics" offering diverse "Unproven Stem Cell Interventions." This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products.The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated "Stem Cell Clinics" offering diverse "Unproven Stem Cell Interventions." This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products. The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated “Stem Cell Clinics” offering diverse “Unproven Stem Cell Interventions.” This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products. Graphical AbstractA broad spectrum of oversight impacts on MSC product safety in patients. We here outline the necessary steps toward integration of highly procoagulant tissue factor (TF/CD142) and hemocompatibility assessment of diversified intravascular MSC products as a new safety criterion into the existing MSC minimal criteria. Regulatory authorities and international societies should undertake coordinated efforts to update the already established guidelines. Abstract The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including rapid growth of poorly regulated “Stem Cell Clinics” offering diverse “Unproven Stem Cell Interventions.” This product diversification necessitates a critical evaluation of the reliance on the 2006 MSC minimal criteria to not only define MSC identity but characterize MSC suitability for intravascular administration. While high-quality MSC therapeutics have been safely administered intravascularly in well-controlled clinical trials, repeated case reports of mild-to-more-severe adverse events have been reported. These are most commonly related to thromboembolic complications upon infusion of highly procoagulant tissue factor (TF/CD142)-expressing MSC products. As TF/CD142 expression varies widely depending on the source and manufacturing process of the MSC product, additional clinical cell product characterization and guidelines are needed to ensure the safe use of MSC products. To minimize risk to patients receiving MSC therapy, we here propose to supplement the minimal criteria used for characterization of MSCs, to include criteria that assess the suitability of MSC products for intravascular use. If cell products are intended for intravascular delivery, which is true for half of all clinical applications involving MSCs, the effects of MSC on coagulation and hemocompatibility should be assessed and expression of TF/CD142 should be included as a phenotypic safety marker. This adjunct criterion will ensure both the identity of the MSCs as well as the safety of the MSCs has been vetted prior to intravascular delivery of MSC products. Graphical Abstract Graphical Abstract A broad spectrum of oversight impacts on MSC product safety in patients. We here outline the necessary steps toward integration of highly procoagulant tissue factor (TF/CD142) and hemocompatibility assessment of diversified intravascular MSC products as a new safety criterion into the existing MSC minimal criteria. Regulatory authorities and international societies should undertake coordinated efforts to update the already established guidelines. |
| Author | Nolta, Jan A Moll, Guido Ankrum, James A Olson, Scott D |
| AuthorAffiliation | 2 Roy J. Carver Department of Biomedical Engineering and Fraternal Order of Eagles Diabetes Research Center, Pappajohn Biomedical Institute, University of Iowa , Iowa City, IA , USA 3 Department of Pediatric Surgery, McGovern Medical School, University of Texas Health Sciences Center at Houston , Houston, TX , USA 4 Director of the Stem Cell Program, University of California Davis School of Medicine , Sacramento, CA , USA 1 BIH Center for Regenerative Therapies (BCRT) and Berlin Brandenburg School of Regenerative Therapies (BSRT), Berlin Institute of Health (BIH) at the Charité—Universitätsmedizin Berlin, corporate member of Freie Universität zu Berlin and Humboldt-Universität zu Berlin , Berlin , Germany |
| AuthorAffiliation_xml | – name: 2 Roy J. Carver Department of Biomedical Engineering and Fraternal Order of Eagles Diabetes Research Center, Pappajohn Biomedical Institute, University of Iowa , Iowa City, IA , USA – name: 1 BIH Center for Regenerative Therapies (BCRT) and Berlin Brandenburg School of Regenerative Therapies (BSRT), Berlin Institute of Health (BIH) at the Charité—Universitätsmedizin Berlin, corporate member of Freie Universität zu Berlin and Humboldt-Universität zu Berlin , Berlin , Germany – name: 4 Director of the Stem Cell Program, University of California Davis School of Medicine , Sacramento, CA , USA – name: 3 Department of Pediatric Surgery, McGovern Medical School, University of Texas Health Sciences Center at Houston , Houston, TX , USA |
| Author_xml | – sequence: 1 givenname: Guido orcidid: 0000-0001-6173-5957 surname: Moll fullname: Moll, Guido email: guido.moll@charite.de organization: BIH Center for Regenerative Therapies (BCRT) and Berlin Brandenburg School of Regenerative Therapies (BSRT), Berlin Institute of Health (BIH) at the Charité—Universitätsmedizin Berlin, corporate member of Freie Universität zu Berlin and Humboldt-Universität zu Berlin, Berlin, Germany – sequence: 2 givenname: James A orcidid: 0000-0003-3959-6158 surname: Ankrum fullname: Ankrum, James A organization: Roy J. Carver Department of Biomedical Engineering and Fraternal Order of Eagles Diabetes Research Center, Pappajohn Biomedical Institute, University of Iowa, Iowa City, IA, USA – sequence: 3 givenname: Scott D orcidid: 0000-0001-8032-3755 surname: Olson fullname: Olson, Scott D organization: Department of Pediatric Surgery, McGovern Medical School, University of Texas Health Sciences Center at Houston, Houston, TX, USA – sequence: 4 givenname: Jan A orcidid: 0000-0003-4576-8542 surname: Nolta fullname: Nolta, Jan A organization: Director of the Stem Cell Program, University of California Davis School of Medicine, Sacramento, CA, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35641163$$D View this record in MEDLINE/PubMed |
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| Copyright | The Author(s) 2022. Published by Oxford University Press. 2022 The Author(s) 2022. Published by Oxford University Press. The Author(s) 2022. Published by Oxford University Press. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | mesenchymal stromal/stem cells (MSCs) product diversification hemocompatibility thromboembolism safety and efficacy coagulopathy cellular therapy tissue source coagulation tissue factor/CD142/Factor III/F3 |
| Language | English |
| License | This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com. https://creativecommons.org/licenses/by-nc/4.0 The Author(s) 2022. Published by Oxford University Press. |
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The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade,... The number of mesenchymal stromal/stem cell (MSC) therapeutics and types of clinical applications have greatly diversified during the past decade, including... |
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| SubjectTerms | Blood Coagulation Case reports Clinical trials Humans Mesenchymal Stem Cell Transplantation - adverse effects Mesenchymal Stem Cells - metabolism Patient safety Stem cells Therapeutic applications Thromboembolism Thromboplastin - metabolism Tissue factor |
| Title | Improved MSC Minimal Criteria to Maximize Patient Safety: A Call to Embrace Tissue Factor and Hemocompatibility Assessment of MSC Products |
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