The objective of the phase I clinical trial was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stromal cells (ASCs) injected into the major salivary glands in cancer patients with salivary glands damaged by irradiation.

This trial provides the first results showing that treatment with an “off-the-shelf” allogeneic ASCs drug into the submandibular and parotid glands of patients with radiation-induced salivary gland hypofunction and xerostomia is safe and potentially effective.

A significant and clinically meaningful increase in unstimulated and stimulated whole saliva flow rate was observed along with decrease in xerostomia and improved patient-reported quality of life.

Lynggaard CD, Grønhøj C, Christensen R, Fischer-Nielsen A, Melchiors J, Specht L, Andersen E, Mortensen J, Oturai P, Hoffmann Barfod G, Kannik Haastrup E, Møller-Hansen M, Haack-Sørensen M, Ekblond E, Kastrup J, Jensen SB and von Buchwald C.
Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-induced Xerostomia- A Safety Study (MESRIX-II).
STEM CELLS Translational Medicine. 2022 Apr 18;szac011.  Doi: 10.1093/stcltm/szac011