- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874572
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth (MESRIX-SAFETY)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
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Copenhagen, Denmark, 2100
- Department of Otolaryngology, Rigshospitalet
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Charlotte Lynggaard, MD, Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVB2018-2
- 2018-003856-19 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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