Xerostomia Due to RadiotherapyPhase 2NCT03743155
Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
A Phase 2 study testing mesenchymal cells in people with Xerostomia Due to Radiotherapy, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
Trial summary
Phase II not controlled, open-label, prospective, single center clinical trial Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xerostomia Due to Radiotherapy
- What is being tested?
- mesenchymal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2018to 30 May 2021
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 75 years old of both sexes.
- Biochemical analysis without significant alterations which could contraindicate the treatment.
- Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
- 2 years of follow-up without recurrence.
- Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
- Grade 1-3 xerostomy as assessed by the grading scale.
- The patient is able to understand the nature of the study.
- Written informed consent of the patient
Who cannot join
- Participation in another clinical trial in the 3 months prior to his/her inclusion.
- Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
- Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
- History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
- Xerogenic medication in progress.
- Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
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- Local infection.
- Pregnancy or pregnancy planned within the next 2 years.
- Breastfeeding.
- Treatment with anticoagulants (not interruptible in MO or application).
- Any other illness or condition that is grounds for exclusion for the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial to Evaluate the Effect and Safety of MSV * in Xerostomia * Adult Autologous Bone Marrow Mesenchymal Stem Cells, Expanded Under GMP of IBGM
Phase II not controlled, open-label, prospective, single center clinical trial
Read the detailed description
- Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study.
- Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL).
- Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast.
- Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).
- Conditions
- Xerostomia Due to Radiotherapy
- Being tested
- mesenchymal cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal cellsBiological
Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration
| Study group | Role | What they receive |
|---|---|---|
| treatment with mesenchymal stem cells | Experimental | xerostomy using mesenchymal stem cells adult autologous bone marrow Receives: Biological: mesenchymal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Measured: 24 months
Changes in the characteristics and degree of discomfort of xerostomia.
Absolute and relative change of the score of the EVA Questionnaire
Measured: 24 months
Sialometry results
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Measured: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (volume) (MRI with contrast)
Measured: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (vascularization) (MRI with contrast)
Measured: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Measured: 24 months
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Measured: 24 months
Secondary outcomes (1)
AEs and SAEs
Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs). It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start15 Dec 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2021 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm due to not alternative treatment exist
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Terapia Regenerativa Tissular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743155
- Sponsor's protocol ID
- XRS-ITRT-2018
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Evaluate the Effect and Safety of MSV * in Xerostomia * Adult Autologous Bone Marrow Mesenchymal Stem Cells, Expanded Under GMP of IBGM
- ClinicalTrials.gov ID
- NCT03743155
- Acronym / sponsor ID
- XRS-ITRT-2018
- Conditions
- Xerostomia Due to Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut de Terapia Regenerativa TissularUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 16 Nov 2018 (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.
Phase II not controlled, open-label, prospective, single center clinical trial
Detailed description
- Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study.
- Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL).
- Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast.
- Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm due to not alternative treatment exist
| Arm | Type | Receives |
|---|---|---|
| treatment with mesenchymal stem cells | Experimental | Biological: mesenchymal cellsxerostomy using mesenchymal stem cells adult autologous bone marrow |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients from 18 to 75 years old of both sexes.
- Biochemical analysis without significant alterations which could contraindicate the treatment.
- Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
- 2 years of follow-up without recurrence.
- Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
Key exclusion criteria (11 listed)
- Participation in another clinical trial in the 3 months prior to his/her inclusion.
- Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
- Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
- History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
- Xerogenic medication in progress.
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 |
|---|---|---|
| mesenchymal cellsAutologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration | Biological | treatment with mesenchymal stem cells |
Primary outcome
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
Time frame: 24 months
Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Changes in the characteristics and degree of discomfort of xerostomia.
Time frame: 24 months
Absolute and relative change of the score of the EVA Questionnaire
Sialometry results
Time frame: 24 months
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Restoration of the glandular structure.
Time frame: 24 months
Changes in the glandular structure (volume) (MRI with contrast)
Restoration of the glandular structure.
Time frame: 24 months
Changes in the glandular structure (vascularization) (MRI with contrast)
Restoration of the glandular structure.
Time frame: 24 months
Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Time frame: 24 months
Measurement of submaxillary gland functionalism changes based on Gammagraphy
1 secondary outcome
AEs and SAEs
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Xerostomia Due to Radiotherapy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mesenchymal cells in people with Xerostomia Due to Radiotherapy, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
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 11 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 16 Nov 2018. 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 Spain. 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 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?
Contact Lluis Orozco, MD (600 421 095, lluis.orozco@itrt.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire (time frame: 24 months). The study lists 7 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 16 Nov 2018.