Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer: study protocol for phase I clinical trial
References
- Borras JM, Barton M, Grau C, Corral J, Verhoeven R, Lemmens V, et al. The impact of cancer incidence and stage on optimal utilization of radiotherapy: methodology of a population based analysis by the ESTRO-HERO project. Radiother Oncol 2015; 116: 45–50. doi: 10.1016/j.radonc.2015.04.021
- Peng X, Wu Y, Brouwer U, van Vliet T, Wang B, Demaria M, et al. Cellular senescence contributes to radiation-induced hyposalivation by affecting the stem/progenitor cell niche. Cell Death Dis 2020; 11: 854. doi: 10.1038/s41419-020-03074-9
- Siddiqui F, Movsas B. Management of radiation toxicity in head and neck cancers. Semin Radiat Oncol 2017; 27: 340–9. doi: 10.1016/j.semradonc.2017.04.008
- Chambers MS, Garden AS, Kies MS, Martin JW. Radiation-induced xerostomia in patients with head and neck cancer: pathogenesis, impact on quality of life, and management. Head Neck 2004; 26: 796–807. doi: 10.1002/hed.20045
- Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, et al. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol 2011; 12: 127–36. doi: 10.1016/S1470-2045(10)70290-4
- Nuyts S, Bollen H, Ng SP, Corry J, Eisbruch A, Mendenhall WM, et al. Proton therapy for squamous cell carcinoma of the head and neck: early clinical experience and current challenges. Cancers 2022; 14: 2587. doi: 10.3390/cancers14112587
- Chen D, Chen X, Chen X, Jiang N, Jiang L. The efficacy of positioning stents in preventing oral complications after head and neck radiotherapy: a systematic literature review. Radiat Oncol 2020; 15: 90. doi: 10.1186/s13014-020-01536-0
- Riley P, Glenny AM, Hua F, Worthington HV. Pharmacological interventions for preventing dry mouth and salivary gland dysfunction following radiotherapy. Cochrane Database Syst Rev 2017; 7: CD012744. doi: 10.1002/14651858.CD012744
- Sood AJ, Fox NF, O’Connell BP, Lovelace TL, Nguyen SA, Sharma AK, et al. Salivary gland transfer to prevent radiation-induced xerostomia: a systematic review and meta-analysis. Oral Oncol 2014; 50: 77–83. doi: 10.1016/j.oraloncology.2013.10.010
- Strojan P, Hutcheson KA, Eisbruch A, Beitler JJ, Langendijk JA, Lee AWM, et al. Treatment of late sequelae after radiotherapy for head and neck cancer. Cancer Treat Rev 2017; 59: 79–92. doi: 10.1016/j.ctrv.2017.07.003
- Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, Leemans CR, Aaronson NK, Slotman BJ. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol 2008; 26: 3770–6. doi: 10.1200/JCO.2007.14.6647
- Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol 2008; 8: 726–36. doi: 10.1038/nri2395
- Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006; 8: 315–7. doi: 10.1080/14653240600855905
- Jiang W, Xu J. Immune modulation by mesenchymal stem cells. Cell Prolif 2020; 53: e12712. doi: 10.1111/cpr.12712
- Li N, Hua J. Interactions between mesenchymal stem cells and the immune system. Cell Mol Life 2017; 74: 2345–60. doi: 10.1007/s00018-017-2473-5
- Di Nicola M, Carlo-Stella C, Magni M, Milanesi M, Longoni PD, Matteucci P, et al. Human bone marrow stromal cells suppress T-lymphocyte proliferation induced by cellular or nonspecific mitogenic stimuli. Blood 2002; 99: 3838–43. doi: 10.1182/blood.v99.10.3838
- Tse WT, Pendleton JD, Beyer WM, Egalka MC, Guinan EC. Suppression of allogeneic T-cell proliferation by human marrow stromal cells: implications in transplantation. Transplantation 2003; 75: 389–97. doi: 10.1097/01.TP.0000045055.63901.A9
- Roncarolo MG, Gregori S, Bacchetta R, Battaglia M. Tr1 cells and the counter-regulation of immunity: natural mechanisms and therapeutic applications. In: Fillatreau S, O’Garra A, editors. Interleukin-10 in health and disease. Berlin, Heidelberg: Springer Berlin Heidelberg; 2014. p. 39–68. doi:
https://doi.org/10.1007/978-3-662-43492-5 - Rasmusson I, Ringden O, Sundberg B, Le Blanc K. Mesenchymal stem cells inhibit the formation of cytotoxic T lymphocytes, but not activated cytotoxic T lymphocytes or natural killer cells. Transplantation 2003; 76: 1208–13. doi: 10.1097/01.TP.0000082540.43730.80
- Angoulvant D, Clerc A, Benchalal S, Galambrun C, Farre A, Bertrand Y, et al. Human mesenchymal stem cells suppress induction of cytotoxic response to alloantigens. Biorheology 2004; 41: 469–76. PMID: 15299278
- Zha K, Li X, Yang Z, Tian G, Sun Z, Sui X, et al. Heterogeneity of mesenchymal stem cells in cartilage regeneration: from characterization to application. NPJ Regen Med 2021; 6: 14. doi: 10.1038/s41536-021-00122-6
- Cottle C, Porter AP, Lipat A, Turner-Lyles C, Nguyen J, Moll G, et al. Impact of cryopreservation and freeze-thawing on therapeutic properties of mesenchymal stromal/stem cells and other common cellular therapeutics. Curr Stem Cell Rep 2022; 8: 72–92. doi: 10.1007/s40778-022-00212-1
- Krampera M, Le Blanc K. Mesenchymal stromal cells: putative microenviron-mental modulators become cell therapy. Cell Stem Cell 2021; 28: 1708–25. doi: 10.1016/j.stem.2021.09.006
- National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 2017. [cited 2023 Apr 14]. Available at:
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf - Navazesh M, Christensen CM. A comparison of whole mouth resting and stimulated salivary measurement procedures. J Dent Res 1982; 61: 1158–62. doi: 10.1177/00220345820610100901
- Goličnik M, Bavec A. Evaluation of the paraoxonase-1 kinetic parameters of the lactonase activity by nonlinear fit of progress curves. J Enzyme Inhib Med Chem 2020; 35: 261–4. doi: 10.1080/14756366.2019.1695792
- Petrič B, Goličnik M, Bavec A. iFIT: an automated web tool for determining enzyme-kinetic parameters based on the high-curvature region of progress curves. Acta Chim Slov 2022; 69: 478–82. doi: 10.17344/acsi.2022.7359
- Petrič B, Redenšek Trampuž S, Dolžan V, Gregorič Krambergar M, Trošt M, Makarović N, et al. Investigation of paraoxonase-1 genotype and enzyme-kinetic parameters in the context of cognitive impairment in parkinson's disease. Antioxidants 2023; 12: 399. doi: 10.3390/antiox12020399
- Pai S, Ghezzi EM, Ship JA. Development of a Visual Analogue Scale questionnaire for subjective assessment of saliveary dysfunction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001; 91: 311–6. doi: 10.1067/moe.2001.111551
- Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-spearing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys 2001; 50: 695–704. doi: 10.1016/s0360-3016(01)01512-7
- Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A; EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring manual. 3rd edition. Brussels: European Organisation for Research and Treatment of Cancer; 2001.
- Jin HJ, Bae YK, Kim M, Kwon SJ, Jeon HB, Choi SJ, et al. Comparative analysis of human mesenchymal stem cells from bone marrow, adipose tissue, and umbilical cord blood as sources of cell therapy. Int J Mol Sci 2013; 14: 17986–8001. doi: 10.3390/ijms140917986
- Primorac D, Molnar V, Matisic V, Hudetz D, Jelec Z, Rod E, et al. Comprehensive review of knee osteoarthritis pharmacological treatment and the latest professional societies’ guidelines. Pharmaceuticals 2021; 14: 205. doi: 10.3390/ph14030205
- Lim JY, Ra JC, Shin IS, Jang YH, An HY, Choi JS, et al. Systemic transplantation of human adipose tissue-derived mesenchymal stem cells for the regeneration of irradiation-induced salivary gland damage. PLoS One 2013; 8: e71167. doi: 10.1371/journal.pone.0071167
- Lim JY, Yi T, Choi JS, Jang YH, Lee S, Kim HJ, et al. Intraglandular transplantation of bone marrow-derived clonal mesenchymal stem cells for amelioration of post-irradiation salivary gland damage. Oral Oncol 2013; 49: 136–43. doi: 10.1016/j.oraloncology.2012.08.010
- Andrzejewska A, Lukomska B, Janowski M. Concise review: mesenchymal stem cells: from roots to boost. Stem Cells 2019; 37: 855–64. doi: 10.1002/stem.3016
- Grønhøj C, Jensen DH, Vester-Glowinski P, Jensen SB, Bardow A, Oliveri RS, et al. Safety and efficacy of mesenchymal stem cells for radiation-induced xerostomia: a randomized, placebo controlled phase 1/2 trial (MESRIX). Int J Radiat Oncol Biol Phys 2018; 101: 581–92. doi: 10.1016/j.ijrobp.2018.02.034
- Lynggaard CD, Gronhoj C, Jensen SB, Christensen R, Specht L, Andersen E, et al. Long-term safety of treatment with autologous mesenchymal stem cells in patients with radiation-induced xerostomia: primary results of the MESRIX phase I/II randomized trial. Clin Cancer Res 2022; 28: 2890–7. doi: 10.1158/1078-0432.CCR-21-4520
- Lynggaard CD, Gronhoj C, Christensen R, Fischer-Nielsen A, Melchiors J, Specht L, et al. Intraglandular off-the-shelf allogeneic mesenchymal stem cell treatment in patients with radiation-induced xerostomia: a safety study (MESRIX-II). Stem Cells Transl Med 2022; 11: 478–89. doi: 10.1093/stcltm/szac011
- Lakota J, Dubrovcakova M, Haider KH. Human mesenchymal stem cells: the art to use them in the treatment of previously untreatable. In: Haider KH, editor. Handbook of stem cell therapy. Singapore: Springer Singapore; 2022. p. 1–20. doi: 10.1007/978-981-16-6016-0
- Blitzer GC, Rogus-Pulia NM, Mattison RJ, Varghese T, Ganz O, Chappell R, et al. Marrow-derived autologous stromal cells for the restoration of salivary hypofunction (MARSH): study protocol for a phase 1 dose-escalation trial of patients with xerostomia after radiation therapy for head and neck cancer. Cytotherapy 2022; 24: 534–43. doi: 10.1016/j.jcyt.2021.11.003
- Blitzer GC, Glazer T, Burr A, Gustafson S, Ganz O, Meyers R, et al. Marrow-derived autologous stromal cells for the restoration of salivary hypofunction (MARSH): a pilot, first-in-human study of interferon gamma-stimulated marrow mesenchymal stromal cells for treatment of radiation-induced xerostomia. Cytotherapy 2023. [Ahead of print]. doi: 10.1016/j.jcyt.2023.07.009
- Moretti P, Hatlapatka T, Marten D, Lavrentieva A, Majore I, Hass R, et al. Mesenchymal stromal cells derived from human umbilical cord tissues: primitive cells with potential for clinical and tissue engineering applications. Adv Biochem Eng Biotechnol 2010; 123: 29–54. doi: 10.1007/10_2009_15
- Bárcia RN, Santos JM, Filipe M, Teixeira M, Martins JP, Almeida J, et al. What makes umbilical cord tissue-derived mesenchymal stromal cells superior immunomodulators when compared to bone marrow derived mesenchymal stromal cells? Stem Cells Int 2015; 2015: 583984. doi: 10.1155/2015/583984
- Kehl D, Generali M, Mallone A, Heller M, Uldry AC, Cheng P, et al. Proteomic analysis of human mesenchymal stromal cell secretomes: a systematic comparison of the angiogenic potential. NPJ Regen Med 2019; 4: 8. doi: 10.1038/s41536-019-0070-y
- Doi H, Kitajima Y, Luo L, Yan C, Tateishi S, Ono Y, et al. Potency of umbilical cord blood and Wharton's jelly-derived mesenchymal stem cells for scarless wound healing. Sci Rep 2016; 6: 18844. doi: 10.1038/srep18844
- Grønhøj C, Jensen DH, Glovinski PV, Jensen SB, Bardow A, Oliveri RS, et al. First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial. Trials 2017; 18: 108. doi: 10.1186/s13063-017-1856-0
Language: English
Page range: 538 - 549
Submitted on: Sep 4, 2023
Accepted on: Sep 25, 2023
Published on: Nov 30, 2023
Published by: Association of Radiology and Oncology
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
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© 2023 Primoz Strojan, Gaber Plavc, Marko Kokalj, Goran Mitrovic, Olga Blatnik, Luka Lezaic, Aljaz Socan, Aljosa Bavec, Natasa Tesic, Katrina Hartman, Urban Svajger, published by Association of Radiology and Oncology
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