{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Criteria for Adverse Events (CTCAE). Since this is a local treatment with MSCs the primary safety measures are: All measures of adverse events will be graded according to Common Terminology","groups":[{"description":"The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the MSC-suspension , the surgeon will identify the submandibular glands and inject the suspension MSCs into the submandibular gland. Calculation of injected number of MSCs pr. participant rests on the following calculation: 2.8 x 10\\^6 MSC / Cm\\^3 X volume , where volume is the volume of the submandibular gland, and a gland-volume of app. 7-8cm3 is the norm. Therefore the amount of cells given to each participant will be app. 4.6 x 10\\^7 MSC in total. Afterwards the participant will be given a band-aid and over the counter analgesics.\n\nMesenchymal stem cell: Stemcells injected into submandibularis","id":"OG000","title":"Stemcells Injected Into Submandibularis"},{"description":"The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the placebo-suspension , the surgeon will identify the submandibular glands and inject the suspension. Placebo will be 2ml of Isotonic NaCl (0,9mg/ml) and HA 1%.\n\nIsotonic NaCl","id":"OG001","title":"Saltwater Injected Into Submandibularis"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"4 months","title":"Number of Participants With Adverse Events as a Measure of Safety","type":"PRIMARY","unitOfMeasure":"participants"}