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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
Last Update Posted : August 21, 2017
Sponsor:
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

  Show Detailed Description

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
U.S. FDA Resources

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: 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


Secondary Outcome Measures :
  1. 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.


  2. 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

    questionnaire.


  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.




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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Grønhøj Larsen, MD, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02513238     History of Changes
Other Study ID Numbers: 1406653
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases