Trial Outcomes & Findings for Mesenchymal Stemcells for Radiation Induced Xerostomia (NCT NCT02513238)

NCT ID: NCT02513238

Last Updated: 2022-12-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2022-12-28

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Stemcells Injected Into Submandibularis n=15 Participants 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	Saltwater Injected Into Submandibularis n=15 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	60 years n=15 Participants	60 years n=15 Participants	60 years n=30 Participants
Sex: Female, Male Female	5 Participants n=15 Participants	5 Participants n=15 Participants	10 Participants n=30 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	10 Participants n=15 Participants	20 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Denmark	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: 4 months

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

Outcome measures

Measure	Stemcells Injected Into Submandibularis n=15 Participants 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	Saltwater Injected Into Submandibularis n=15 Participants 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
Number of Participants With Adverse Events as a Measure of Safety	0 participants	0 participants

Adverse Events

Stemcells Injected Into Submandibularis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saltwater Injected Into Submandibularis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator, Mesrix

Rigshospitalet

Phone: 26276374

Email: c.gronhoj@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place