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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874572
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Charlotte Lynggaard, Rigshospitalet, Denmark

Brief Summary:
An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

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:

Patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived MSCs into the submandibular and parotid glands. The trial will be Good Clinical Practice (GCP) Monitored. From healthy donors, MSCs will be produced at a Good Manufacturing Practice (GMP) Facility.

The patients will be followed for four months for safety, tolerability, and efficacy registration. Changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. Immune response towards receiving allogeneic MSCs will be evaluated in plasma and saliva. Changes in the composition and quality of the whole saliva will be investigated.

Saliva from the participants will altså be compared to saliva from ten healthy controls.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Actual Primary Completion Date : June 22, 2020
Estimated Study Completion Date : December 1, 2025

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 reponse :Development of donor specific antibodies [ Time Frame: 4 months ]
    Registration of development of tissue antibodies towards donor cells

  2. Efficacy: Change in Unstimulated Whole Salivary flow rate [ Time Frame: 4 months ]
    Unstimulated whole saliva flow rate is assessed by sialometry

  3. Efficacy: Change in Stimulated Whole Salivary flow rate [ Time Frame: 4 months ]
    Unstimulated whole saliva flow rate is assessed by sialometry

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

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

  6. Efficacy: Change in Saliva composition [ Time Frame: 4 months ]
    Change in inorganic saliva composition

  7. Efficacy: Change in Saliva Proteomics [ Time Frame: 4 months ]
    Change in Saliva proteomics

  8. Efficacy: Change in RNA in Saliva [ Time Frame: 4 months ]
    Change in RNA in saliva

  9. Immune reponse [ Time Frame: 4 months ]
    Reactions in plasma and saliva will be assessed



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03874572


Locations
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Denmark
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
Copenhagen, Denmark, 2100
Department of Otolaryngology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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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
ClinicalTrials.gov Identifier: NCT03874572    
Other Study ID Numbers: CVB2018-2
2018-003856-19 ( EudraCT Number )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
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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Oropharyngeal Neoplasms
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases