Journal article
Improved MSC Minimal Criteria to Maximize Patient Safety: A Call to Embrace Tissue Factor and Hemocompatibility Assessment of MSC Products
Stem cells translational medicine, Vol.11(1), pp.2-13
03/03/2022
DOI: 10.1093/stcltm/szab005
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.
Details
- Title: Subtitle
- Improved MSC Minimal Criteria to Maximize Patient Safety: A Call to Embrace Tissue Factor and Hemocompatibility Assessment of MSC Products
- Creators
- Guido Moll - Charité - Universitätsmedizin BerlinJames A Ankrum - Univ Iowa, Roy J Carver Dept Biomed Engn, Pappajohn Biomed Inst, Iowa City, IA USAScott D Olson - Univ Texas Hlth Sci Ctr Houston, McGovern Med Sch, Dept Pediat Surg, Houston, TX 77030 USAJan A Nolta - University of California, Davis
- Resource Type
- Journal article
- Publication Details
- Stem cells translational medicine, Vol.11(1), pp.2-13
- DOI
- 10.1093/stcltm/szab005
- ISSN
- 2157-6564
- eISSN
- 2157-6580
- Publisher
- Oxford Univ Press
- Number of pages
- 12
- Grant note
- Claire Glassell Stem Cell Gift R01NS102486; R24ODO21606 / NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA GSC203 / German Research Foundation (DFG); German Research Foundation (DFG) 733006; 779293 / European Union's Horizon 2020 research and innovation program Athersys, Biostage, Hope Bio, and Generate Life Sciences TIRR Foundation-Mission Connect Fraternal Order of Eagles Diabetes Research Center California Institute for Regenerative Medicine (CIRM); California Institute for Regenerative Medicine R21NS116302 / NINDS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Neurological Disorders & Stroke (NINDS) GSC203 / German Federal Ministry of Education and Research (BMBF); Federal Ministry of Education & Research (BMBF) Straub Foundation Grace Reynolds Wall Research Fund University of Texas Health Science Center at Houston
- Language
- English
- Date published
- 03/03/2022
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Fraternal Order of Eagles Diabetes Research Center
- Record Identifier
- 9984230416202771
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