Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
- Conditions
- Xerostomia Due to Radiotherapy
- Interventions
- Biological: mesenchymal cells
- Registration Number
- NCT03743155
- Lead Sponsor
- Institut de Terapia Regenerativa Tissular
- Brief Summary
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment with mesenchymal stem cells mesenchymal cells xerostomy using mesenchymal stem cells adult autologous bone marrow
- Primary Outcome Measures
Name Time Method Restoration of the glandular structure. 24 months Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Measurement of submaxillary gland functionalism changes based on Gammagraphy 24 months Measurement of submaxillary gland functionalism changes based on Gammagraphy
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire 24 months Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Sialometry results 24 months Absolute and relative change in the volume of saliva (ml / min) submaxillary
Changes in the characteristics and degree of discomfort of xerostomia. 24 months Absolute and relative change of the score of the EVA Questionnaire
- Secondary Outcome Measures
Name Time Method AEs and SAEs 24 months 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
Trial Locations
- Locations (1)
Institut de Terapia Regenerativa Tissular
🇪🇸Barcelona, Spain