Xerostomia Due to RadiotherapyPhase 1MESRIX-SAFETYNCT03874572
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth
A Phase 1 study testing Allogeneic adipose derived stem/stromal cells in people with Xerostomia Due to Radiotherapy and Hyposalivation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia Due to Radiotherapy, Hyposalivation, Xerostomia
- What is being tested?
- Allogeneic adipose derived stem/stromal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- 18 Mar 2019to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
Copenhagen, 2100
Department of Otolaryngology, Rigshospitalet
Copenhagen, 2100
About this study
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
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
Read the 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.
- Conditions
- Xerostomia Due to Radiotherapy, Hyposalivation, Xerostomia, Oropharynx Cancer, Salivary Gland Diseases, Dry Mouth
- Being tested
- Allogeneic adipose derived stem/stromal cells
- Keywords
- Xerostomia Due to Radiotherapy
- Medical subject headings
- Xerostomia, Oropharyngeal Neoplasms, Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose derived stem/stromal cellsBiological
Culture expanded allogeneic adipose derived stem/stromal cells
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic mesenchymal stem/stromal cell therapy | Experimental | Treatment with intra-glandular Injections of allogeneic adipose derived stem cells Receives: Biological: Allogeneic adipose derived stem/stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of patients with serious adverse events
Registration of number of patients with serious adverse events in a 4 months follow-up period
Measured: 4 months
Secondary outcomes (9)
Immune reponse :Development of donor specific antibodies
Registration of development of tissue antibodies towards donor cells
Measured: 4 months
Efficacy: Change in Unstimulated Whole Salivary flow rate
Unstimulated whole saliva flow rate is assessed by sialometry
Measured: 4 months
Efficacy: Change in Stimulated Whole Salivary flow rate
Unstimulated whole saliva flow rate is assessed by sialometry
Measured: 4 months
Efficacy: Change in quality of life
Change in quality of life evaluted by QLQ-H\&N-35 and XQ questionnaires
Measured: 4 months
Efficacy: Salivary gland function
Assessed by salivary gland 99mTc scintigraphy
Measured: 4 months
Efficacy: Change in Saliva composition
Change in inorganic saliva composition
Measured: 4 months
Efficacy: Change in Saliva Proteomics
Change in Saliva proteomics
Measured: 4 months
Efficacy: Change in RNA in Saliva
Change in RNA in saliva
Measured: 4 months
Immune reponse
Reactions in plasma and saliva will be assessed
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start18 Mar 2019
- Primary completion22 Jun 2020
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to RadiotherapyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Lynggaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Charlotte Lynggaard, MD, Principal investigator, Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874572
- Sponsor's protocol ID
- CVB2018-2
- Other IDs
- 2018-003856-19, 2018
- Acronym
- MESRIX-SAFETY
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03874572
- Acronym / sponsor ID
- MESRIX-SAFETY / CVB2018-2
- Conditions
- Xerostomia Due to Radiotherapy, Hyposalivation, Xerostomia, Oropharynx Cancer, Salivary Gland Diseases, Dry Mouth
- Keywords
- Xerostomia Due to Radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic mesenchymal stem/stromal cell therapy | Experimental | Biological: Allogeneic adipose derived stem/stromal cellsTreatment with intra-glandular Injections of allogeneic adipose derived stem cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic adipose derived stem/stromal cellsCulture expanded allogeneic adipose derived stem/stromal cells | Biological | Allogeneic mesenchymal stem/stromal cell therapy |
Primary outcome
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
9 secondary outcomes
Immune reponse :Development of donor specific antibodies
Time frame: 4 months
Efficacy: Change in Unstimulated Whole Salivary flow rate
Time frame: 4 months
Efficacy: Change in Stimulated Whole Salivary flow rate
Time frame: 4 months
Efficacy: Change in quality of life
Time frame: 4 months
Efficacy: Salivary gland function
Time frame: 4 months
Efficacy: Change in Saliva composition
Time frame: 4 months
Efficacy: Change in Saliva Proteomics
Time frame: 4 months
Efficacy: Change in RNA in Saliva
Time frame: 4 months
Immune reponse
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Xerostomia Due to Radiotherapy
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Lynggaard, MD principal investigator
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic adipose derived stem/stromal cells in people with Xerostomia Due to Radiotherapy and Hyposalivation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of patients with serious adverse events (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.