Radiation ToxicityPhase 1/2NCT03876197
Mesenchymal Stem Cells for Radiation-induced Xerostomia
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem/stromal cells in people with Radiation Toxicity and Xerostomia Due to Radiotherapy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Radiation Toxicity, Xerostomia Due to Radiotherapy, Dry Mouth
- What is being tested?
- Autologous adipose-derived mesenchymal stem/stromal cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2020to 1 Dec 2023
- Phase
- Phase 1/2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
- Subjects who were treated with either autologous mesenchymal stem cells or placebo
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial
Who cannot join
- 1. Subjects who were not enrolled in the MESRIX trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, University Hospital of Copenhagen
Copenhagen
About this study
Official title: Follow-up Study of Safety and Efficacy in Subjects Who Participated in the Study of Intraglandular Mesenchymal Stem Cells in Patients With Radiation-induced Hyposalivation and Xerostomia (MESRIX)
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.
Read the detailed description
This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death
- Conditions
- Radiation Toxicity, Xerostomia Due to Radiotherapy, Dry Mouth, Hyposalivation, Mesenchymal Stem Cells, Mesenchymal Stromal Cells
- Being tested
- Autologous adipose-derived mesenchymal stem/stromal cells, Placebo
- Keywords
- Xerostomia Due to Radiotherapy
- Medical subject headings
- Radiation Injuries, Xerostomia, Long Term Adverse Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived mesenchymal stem/stromal cellsBiological
Autologous adipose-derived mesenchymal stem/stromal cells
PlaceboOther
Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose-derived mesenchymal stem cells | Experimental | Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia Receives: Biological: Autologous adipose-derived mesenchymal stem/stromal cells |
| Placebo | Placebo comparator | 2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1% Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Serious Adverse Events (SAEs) and new chronic diseases
SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients
Measured: 5 years from randomization
Overall survival
Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive
Measured: 5 years from randomization
Relapse of oropharyngeal cancer
Number of participants with relapse will be reported
Measured: 5 years from randomization
New malignancies
Number of subjects who have new malignancies will be reported
Measured: 5 years from randomization
Zoonotic Diseases
Number of subjects diagnosed Zoonotic Diseases will be reported
Measured: 5 years from randomization
Secondary outcomes (1)
Patient-reported outcome measures-Health-related quality of life (HRQoL
Xerostomia Questionnaire (XQ) ( Median item scores for each of the 8 questions will be reported (score range 0-10) and the XQ summary/composite score (0-100))
Measured: 5 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Aug 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Long-term follow-up of Randomized controlled trial MESRIX
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
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, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876197
- Sponsor's protocol ID
- CVB2019-1
- Other IDs
- 2014-004349-29, 2014
- Status last verified
- Oct 2020
- First submitted
- 12 Mar 2019
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Safety and Efficacy in Subjects Who Participated in the Study of Intraglandular Mesenchymal Stem Cells in Patients With Radiation-induced Hyposalivation and Xerostomia (MESRIX)
- ClinicalTrials.gov ID
- NCT03876197
- Acronym / sponsor ID
- CVB2019-1
- Conditions
- Radiation Toxicity, Xerostomia Due to Radiotherapy, Dry Mouth, Hyposalivation, Mesenchymal Stem Cells, Mesenchymal Stromal Cells
- Keywords
- Xerostomia Due to Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 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.
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.
Detailed description
This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Long-term follow-up of Randomized controlled trial MESRIX
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose-derived mesenchymal stem cells | Experimental | Biological: Autologous adipose-derived mesenchymal stem/stromal cellsAutologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia |
| Placebo | Placebo comparator | Other: Placebo2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1% |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
- Subjects who were treated with either autologous mesenchymal stem cells or placebo
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial
Key exclusion criteria (1 listed)
- 1. Subjects who were not enrolled in the MESRIX trial
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 |
|---|---|---|
| Autologous adipose-derived mesenchymal stem/stromal cellsAutologous adipose-derived mesenchymal stem/stromal cells | Biological | Autologous Adipose-derived mesenchymal stem cells |
| PlaceboIsotonic NaCl (0,9mg/ml) and human albumin (HA) 1% | Other | Placebo |
Primary outcome
Safety: Serious Adverse Events (SAEs) and new chronic diseases
Time frame: 5 years from randomization
SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients
Overall survival
Time frame: 5 years from randomization
Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive
Relapse of oropharyngeal cancer
Time frame: 5 years from randomization
Number of participants with relapse will be reported
New malignancies
Time frame: 5 years from randomization
Number of subjects who have new malignancies will be reported
Zoonotic Diseases
Time frame: 5 years from randomization
Number of subjects diagnosed Zoonotic Diseases will be reported
1 secondary outcome
Patient-reported outcome measures-Health-related quality of life (HRQoL
Time frame: 5 years from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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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, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem/stromal cells in people with Radiation Toxicity and Xerostomia Due to Radiotherapy, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 3 inclusion and 1 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Serious Adverse Events (SAEs) and new chronic diseases (time frame: 5 years from randomization). The study lists 5 primary outcomes in all. 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 22 Oct 2020.