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/stem 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.