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

Primary Purpose

Xerostomia Due to Radiotherapy, Hyposalivation, Xerostomia

Status
Active
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Allogeneic adipose derived stem/stromal cells
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia Due to Radiotherapy focused on measuring Xerostomia Due to Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeneic mesenchymal stem/stromal cell therapy

Arm Description

Treatment with intra-glandular Injections of allogeneic adipose derived stem cells

Outcomes

Primary Outcome Measures

Safety: Number of patients with serious adverse events
Registration of number of patients with serious adverse events in a 4 months follow-up period

Secondary Outcome Measures

Immune reponse :Development of donor specific antibodies
Registration of development of tissue antibodies towards donor cells
Efficacy: Change in Unstimulated Whole Salivary flow rate
Unstimulated whole saliva flow rate is assessed by sialometry
Efficacy: Change in Stimulated Whole Salivary flow rate
Unstimulated whole saliva flow rate is assessed by sialometry
Efficacy: Change in quality of life
Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires
Efficacy: Salivary gland function
Assessed by salivary gland 99mTc scintigraphy
Efficacy: Change in Saliva composition
Change in inorganic saliva composition
Efficacy: Change in Saliva Proteomics
Change in Saliva proteomics
Efficacy: Change in RNA in Saliva
Change in RNA in saliva
Immune reponse
Reactions in plasma and saliva will be assessed

Full Information

First Posted
March 12, 2019
Last Updated
January 27, 2021
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03874572
Brief Title
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth
Acronym
MESRIX-SAFETY
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia Due to Radiotherapy, Hyposalivation, Xerostomia, Oropharynx Cancer, Salivary Gland Diseases, Dry Mouth, Mesenchymal Stem Cells, Mesenchymal Stromal Cells, Stem Cells
Keywords
Xerostomia Due to Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic mesenchymal stem/stromal cell therapy
Arm Type
Experimental
Arm Description
Treatment with intra-glandular Injections of allogeneic adipose derived stem cells
Intervention Type
Biological
Intervention Name(s)
Allogeneic adipose derived stem/stromal cells
Intervention Description
Culture expanded allogeneic adipose derived stem/stromal cells
Primary Outcome Measure Information:
Title
Safety: Number of patients with serious adverse events
Description
Registration of number of patients with serious adverse events in a 4 months follow-up period
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Immune reponse :Development of donor specific antibodies
Description
Registration of development of tissue antibodies towards donor cells
Time Frame
4 months
Title
Efficacy: Change in Unstimulated Whole Salivary flow rate
Description
Unstimulated whole saliva flow rate is assessed by sialometry
Time Frame
4 months
Title
Efficacy: Change in Stimulated Whole Salivary flow rate
Description
Unstimulated whole saliva flow rate is assessed by sialometry
Time Frame
4 months
Title
Efficacy: Change in quality of life
Description
Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires
Time Frame
4 months
Title
Efficacy: Salivary gland function
Description
Assessed by salivary gland 99mTc scintigraphy
Time Frame
4 months
Title
Efficacy: Change in Saliva composition
Description
Change in inorganic saliva composition
Time Frame
4 months
Title
Efficacy: Change in Saliva Proteomics
Description
Change in Saliva proteomics
Time Frame
4 months
Title
Efficacy: Change in RNA in Saliva
Description
Change in RNA in saliva
Time Frame
4 months
Title
Immune reponse
Description
Reactions in plasma and saliva will be assessed
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18-75 years Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017) 2 years' follow-up without recurrence Clinically reduced salivation and hyposalivation, evaluated by a screening Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min Grade 2-3 xerostomia (CTCAEv5.0) WHO Performance status (PS) 0-1 Informed consent Exclusion Criteria: Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas) Xerogenic medications Penicillin or Streptomycin allergy Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis Previous parotid or submandibular gland surgery Previous treatment with any type of stem cells Breastfeeding, Pregnancy or planned pregnancy within the next 2 years Smoking within the previous 6 months. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3) Any other disease/condition judged by the investigator to be grounds for exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Lynggaard, MD
Organizational Affiliation
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Otolaryngology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

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