Mesenchymal Stemcells for Radiation Induced Xerostomia (MESRIX)
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|ClinicalTrials.gov Identifier: NCT02513238|
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia||Drug: Mesenchymal stem cell Drug: Isotonic NaCl||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mesenchymal Stem Cells for Radiation-induced Xerostomia (MESRIX) in Previous HPV-positive Oropharyngeal Head and Neck Cancer Patients - A Safety and Feasibility Study|
|Actual Study Start Date :||August 8, 2015|
|Actual Primary Completion Date :||April 6, 2017|
|Actual Study Completion Date :||April 6, 2017|
Active Comparator: 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.
Drug: Mesenchymal stem cell
Stemcells injected into submandibularis
Placebo Comparator: 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%.
Drug: Isotonic NaCl
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 2 years ]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
- Change in whole saliva production [ Time Frame: 4 months ]
Significant increase in unstimulated and stimulated whole saliva flow rate in the group
receiving MSCs, compared with the group of participants receiving placebo (control group).
Salivary flow rate will be calculated as a change in the participant's saliva flow rate from
before intervention (baseline) to four months after.
- Subjective complaints of xerostomia [ Time Frame: 4 months ]
Significant decrease in complaints of xerostomia in the group receiving MSCs compared
with the group of participants receiving placebo as evaluated by a physician and patient
- Change in volume and vascularisation - MRI of glands - composite [ Time Frame: 4 moths ]Measurement of 4-months volume change and tissue vascularisation of submandibular glands based on magnetic resonance imaging (MRI). Calculated as a change after 4 months compared to MRI before intervention (baseline).
- MRI - Change in fibrosis [ Time Frame: 4 moths ]Estimation of change in the amount of fibrosis from the MRI-scan between intervention and placebo group.
- histological sections - gland tissue - composite [ Time Frame: 4 months ]Estimation of the change in the amount of serous and mucinous gland tissue in histological sections from the biopsies taken pre- (baseline) and post-interventional.
- histological sections - fibrosus [ Time Frame: 4 months ]Estimation in the change in fibrosis in histological sections from the biopsies taken pre (baseline) and post-interventional.
- histological sections - vascularisation [ Time Frame: 4 months ]
Estimation in the change in vascularisation in histological sections from the biopsies taken
pre- (baseline) and post-interventional.