Xerostomia post radiotherapy MedDRA version: 20.0 Level: LLT Classification code 10048223 Term: Xerostomia System Organ Class: 100000004856
Conditions
Interventions
Product Name: MSV -células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos GMP
Pharmaceutical Form: Living tissue equivalent
INN or Pro
Sponsors
Institut de Terapia Regenerativa Tissular S.L. (ITRT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients from 18 to 75 years old of both sexes. 2. Biochemical analysis without significant alterations which could contraindicate the treatment. 3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a. 4. 2 years of follow-up without recurrence. 5. 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. 6. Grade 1-3 xerostomy as assessed by the grading scale. 7. The patient is able to understand the nature of the study. 8. Written informed consent of the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial in the 3 months prior to his/her inclusion. 2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion). 3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load. 4. 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. 5. Xerogenic medication in progress. 6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc. 7. Local infection. 8. Pregnancy or pregnancy planned within the next 2 years. 9. Breastfeeding. 10. Treatment with anticoagulants (not interruptible in MO or application). 11. Any other illness or condition that is grounds for exclusion for the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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). ;Secondary Objective: - Determine the Safety of the proposed procedure by recording adverse events (AEs) and serious adverse events (SAEs).; Primary end point(s): - Changes in the OHIP Questionnaire (OHIP-14-sp) and EVA of xerostomia to determine the changes in the characteristics and degree of discomfort of xerostomia. - Restoration or increase of salivary function to determine the volume of submaxilla saliva without stimulation and with stimulation (sialometry). - Restoration of the glandular structure (volume, vascularization and fibrosis of submaxillary glands) by means of NMR with contrast that denote changes in its volume and fibrosis. - Measurement of submaxillary gland functionalism changes through gammagraphy. ;Timepoint(s) of evaluation of this end point: 12 months + 12 months for safety (outside the clinical trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 12 months + 12 months for safety (outside the clinical trial) | — |
Countries
Spain
Contacts
Public ContactProject Coordinator
Institut de Terapia Regenerativa Tissular S.L.
Outcome results
None listed