Phase II not controlled, open-label, prospective, single center clinical trial
* 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Institut de Terapia Regenerativa Tissular
Barcelona, Spain
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)
Time frame: 24 months
Changes in the characteristics and degree of discomfort of xerostomia.
Absolute and relative change of the score of the EVA Questionnaire
Time frame: 24 months
Sialometry results
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Time frame: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (volume) (MRI with contrast)
Time frame: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (vascularization) (MRI with contrast)
Time frame: 24 months
Restoration of the glandular structure.
Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)
Time frame: 24 months
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Time frame: 24 months
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
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Time frame: 24 months