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Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth (MESRIX-SAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03874572
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : May 29, 2019
Information provided by (Responsible Party):
Charlotte Lynggaard, Rigshospitalet, Denmark

Brief Summary:
The current study investigates the feasibility and safety of allogeneic mesenchymal stem/stromal cells in previous oropharynx cancer patients with radiation-induced hyposalivation and xerostomia

Condition or disease Intervention/treatment Phase
Xerostomia Due to Radiotherapy Hyposalivation Xerostomia Oropharynx Cancer Salivary Gland Diseases Dry Mouth Mesenchymal Stem Cells Mesenchymal Stromal Cells Stem Cells Biological: Allogeneic adipose derived stem/stromal cells Phase 1

Detailed Description:

Hyposalivation and xerostomia are the most common long-term side effects to radiotherapy of head and neck cancers.

A randomized clinical trial indicates that autologeous mesenchymal stem/stromal cells can restore function of the submandibular glands.

Patients with previous oropharynx cancer and radiation-induced hyposalivation and xerostomia will be treated with culture expanded adipose tissue derived mesenchymal stem/stromal cells from healthy donors.

The patients will be followed for 4 months for safety and efficacy registration

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia in Previous Oropharynx Cancer Patients
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Allogeneic mesenchymal stem/stromal cell therapy
Treatment with intra-glandular Injections of allogeneic adipose derived stem cells
Biological: Allogeneic adipose derived stem/stromal cells
Culture expanded allogeneic adipose derived stem/stromal cells

Primary Outcome Measures :
  1. Safety: Number of patients with serious adverse events [ Time Frame: 4 months ]
    Registration of number of patients with serious adverse events in a 4 months follow-up period

Secondary Outcome Measures :
  1. Immune response to treatment with allogeneic stem cells [ Time Frame: 4 months ]
    Registration of development of tissue antibodies towards donor cells

  2. Efficacy: Salivary gland function flow rate [ Time Frame: 4 months ]
    Change in unstimulated Whole saliva flow rate (Sialometry)

  3. Efficacy: Change in quality of life [ Time Frame: 4 months ]
    Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires

  4. Efficacy: Salivary gland function [ Time Frame: 4 months ]
    Assessed by salivary gland 99mTc scintigraphy

  5. Efficacy: Function of stimulated Whole saliva [ Time Frame: 4 months ]
    LC-MSMS analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age between 18-75 years
  2. Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
  3. 2 years' follow-up without recurrence
  4. Clinically reduced salivation and hyposalivation, evaluated by a screening
  5. Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
  6. Grade 2-3 xerostomia (CTCAEv5.0)
  7. WHO Performance status (PS) 0-1
  8. Informed consent

Exclusion Criteria:

  1. Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
  2. Xerogenic medications
  3. Penicillin or Streptomycin allergy
  4. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
  5. Previous parotid or submandibular gland surgery
  6. Previous treatment with any type of stem cells
  7. Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
  8. Smoking within the previous 6 months.
  9. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)
  10. Any other disease/condition judged by the investigator to be grounds for exclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03874572

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Contact: Charlotte Lynggaard, MD +45 61242795
Contact: Christian Buchwald, Professor +45 35452370

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Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen Enrolling by invitation
Copenhagen, Denmark, 2100
Department of Otolaryngology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Charlotte Lynggaard, MD    +4561242795   
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Charlotte Lynggaard, MD Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

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Responsible Party: Charlotte Lynggaard, Principal Investigator, Rigshospitalet, Denmark Identifier: NCT03874572     History of Changes
Other Study ID Numbers: CVB2018-2
2018-003856-19 ( EudraCT Number )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol will be submitted with the data of the study
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charlotte Lynggaard, Rigshospitalet, Denmark:
Xerostomia Due to Radiotherapy
Additional relevant MeSH terms:
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Mouth Diseases
Oropharyngeal Neoplasms
Salivary Gland Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Otorhinolaryngologic Diseases