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

January 27, 2021 updated by: Charlotte Lynggaard, Rigshospitalet, Denmark

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
      • Copenhagen, Denmark, 2100
        • Department of Otolaryngology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Allogeneic mesenchymal stem/stromal cell therapy
Treatment with intra-glandular Injections of allogeneic adipose derived stem cells
Culture expanded allogeneic adipose derived stem/stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune reponse :Development of donor specific antibodies
Time Frame: 4 months
Registration of development of tissue antibodies towards donor cells
4 months
Efficacy: Change in Unstimulated Whole Salivary flow rate
Time Frame: 4 months
Unstimulated whole saliva flow rate is assessed by sialometry
4 months
Efficacy: Change in Stimulated Whole Salivary flow rate
Time Frame: 4 months
Unstimulated whole saliva flow rate is assessed by sialometry
4 months
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 months
Efficacy: Salivary gland function
Time Frame: 4 months
Assessed by salivary gland 99mTc scintigraphy
4 months
Efficacy: Change in Saliva composition
Time Frame: 4 months
Change in inorganic saliva composition
4 months
Efficacy: Change in Saliva Proteomics
Time Frame: 4 months
Change in Saliva proteomics
4 months
Efficacy: Change in RNA in Saliva
Time Frame: 4 months
Change in RNA in saliva
4 months
Immune reponse
Time Frame: 4 months
Reactions in plasma and saliva will be assessed
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlotte Lynggaard, MD, Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2019

Primary Completion (ACTUAL)

June 22, 2020

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (ACTUAL)

March 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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