NCT02513238 · ADVERSE EVENTS

Adverse events

Mesenchymal Stemcells for Radiation Induced Xerostomia · Source last updated 2022-12-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 9 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stemcells Injected Into Submandibularis 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. Mesenchymal stem cell: Stemcells injected into submandibularis	0 / 15	0 / 15	0 / 15
Saltwater Injected Into Submandibularis 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%. Isotonic NaCl	0 / 15	0 / 15	0 / 15

Group identifiers: EG000: Stemcells Injected Into Submandibularis · EG001: Saltwater Injected Into Submandibularis

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
15
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. Mesenchymal stem cell: Stemcells injected into submandibularis
id
EG000
other Num Affected
0
other Num At Risk
15
serious Num Affected
0
serious Num At Risk
15
title
Stemcells Injected Into Submandibularis
deaths Num Affected
0
deaths Num At Risk
15
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%. Isotonic NaCl
id
EG001
other Num Affected
0
other Num At Risk
15
serious Num Affected
0
serious Num At Risk
15
title
Saltwater Injected Into Submandibularis

frequency Threshold

time Frame

9 months

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Preserved source evidence · Not medical advice