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Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II)

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  • Charlotte Duch Lynggaard, University of Copenhagen, The Parker Institute
  • ,
  • Christian Grønhøj, University of Copenhagen, Denmark
  • Robin Christensen, Parker Institute, University of Southern Denmark, Denmark
  • Anne Fischer-Nielsen, University of Copenhagen
  • ,
  • Jacob Melchiors, University of Copenhagen
  • ,
  • Lena Specht, University of Copenhagen, Denmark
  • Elo Andersen, University of Copenhagen, Denmark
  • Jann Mortensen, University of Copenhagen, Denmark
  • Peter Sandor Oturai, University of Copenhagen
  • ,
  • Gry Hoffmann Barfod
  • Eva Kannik Haastrup, University of Copenhagen
  • ,
  • Michael Møller-Hansen, University of Copenhagen
  • ,
  • Mandana Haack-Sørensen, University of Copenhagen
  • ,
  • Annette Ekblond, University of Copenhagen, Denmark
  • Jens Kastrup, University of Copenhagen, Denmark
  • Siri Beier Jensen
  • Christian von Buchwald, University of Copenhagen, Denmark

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 \n(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 \n(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.

Original languageEnglish
JournalStem Cells Translational Medicine
Pages (from-to)478-489
Number of pages12
Publication statusPublished - May 2022

    Research areas

  • HEAD, IMPACT, LIFE, MECHANISMS, SALIVARY, cancer, clinical trials, mesenchymal stem cells, stem cells, xerostomia

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