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Mesenchymal Stemcells for Radiation Induced Xerostomia (MESRIX)

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ClinicalTrials.gov Identifier: NCT02513238
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : December 28, 2022
Last Update Posted : December 28, 2022
Information provided by (Responsible Party):
Christian Grønhøj Larsen, Rigshospitalet, Denmark

Brief Summary:
The current study aims to assess the safety and feasibility of the injection of autologous adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia in head and neck cancer participants. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after radiotherapy. The development of new therapies is especially important, since only sub-optimal symptomatic treatments are currently available and the symptom of xerostomia greatly reduces the quality of life.

Condition or disease Intervention/treatment Phase
Xerostomia Drug: Mesenchymal stem cell Drug: Isotonic NaCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.

  • 2 years follow-up without recurrence
  • Clinically reduced salivation and hyposalivation, evaluated by a screening
  • Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min
  • Only participants with previous T1-T2 and N0, N1 or N2a.
  • Informed consent
  • Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale

Exclusion Criteria:

  • Any cancer in the previous 2 years
  • Xerogenic medications
  • Any other diseases of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc.
  • Pregnancy or planned pregnancy within the next 2 years
  • Breastfeeding
  • Any other disease/condition judged by the investigator to be grounds for exclusion
  • Treatment with anticoagulant that cannot be stopped during the intervention period.
  Study Documents (Full-Text)

Documents provided by Christian Grønhøj Larsen, Rigshospitalet, Denmark:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Grønhøj Larsen, MD, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02513238    
Other Study ID Numbers: 1406653
First Posted: July 31, 2015    Key Record Dates
Results First Posted: December 28, 2022
Last Update Posted: December 28, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases