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
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