Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II)
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Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia : A Safety Study (MESRIX-II). / Lynggaard, Charlotte Duch; Grønhøj, Christian; Christensen, Robin; Fischer-Nielsen, Anne; Melchiors, Jacob; Specht, Lena; Andersen, Elo; Mortensen, Jann; Oturai, Peter; Barfod, Gry Hoffmann; Haastrup, Eva Kannik; Møller-Hansen, Michael; Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens; Jensen, Siri Beier; von Buchwald, Christian.
I: Stem Cells Translational Medicine, Bind 11, Nr. 5, 2022, s. 478-489.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia
T2 - A Safety Study (MESRIX-II)
AU - Lynggaard, Charlotte Duch
AU - Grønhøj, Christian
AU - Christensen, Robin
AU - Fischer-Nielsen, Anne
AU - Melchiors, Jacob
AU - Specht, Lena
AU - Andersen, Elo
AU - Mortensen, Jann
AU - Oturai, Peter
AU - Barfod, Gry Hoffmann
AU - Haastrup, Eva Kannik
AU - Møller-Hansen, Michael
AU - Haack-Sørensen, Mandana
AU - Ekblond, Annette
AU - Kastrup, Jens
AU - Jensen, Siri Beier
AU - von Buchwald, Christian
N1 - Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press.
PY - 2022
Y1 - 2022
N2 - No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)-xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.
AB - No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)-xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.
KW - cancer
KW - clinical trials
KW - mesenchymal stem cells
KW - stem cells
KW - xerostomia
U2 - 10.1093/stcltm/szac011
DO - 10.1093/stcltm/szac011
M3 - Journal article
C2 - 35435231
AN - SCOPUS:85131225099
VL - 11
SP - 478
EP - 489
JO - Stem cells translational medicine
JF - Stem cells translational medicine
SN - 2157-6564
IS - 5
ER -
ID: 320013880