Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase II not controlled, open-label, prospective, single center clinical trial
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment with mesenchymal stem cells | Experimental | xerostomy using mesenchymal stem cells adult autologous bone marrow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal cells | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 months |
| Changes in the characteristics and degree of discomfort of xerostomia. | Absolute and relative change of the score of the EVA Questionnaire | 24 months |
| Sialometry results | Absolute and relative change in the volume of saliva (ml / min) submaxillary | 24 months |
| Restoration of the glandular structure. | Changes in the glandular structure (volume) (MRI with contrast) | 24 months |
| Restoration of the glandular structure. | Changes in the glandular structure (vascularization) (MRI with contrast) | 24 months |
| Restoration of the glandular structure. | Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast) | 24 months |
| Measurement of submaxillary gland functionalism changes based on Gammagraphy | Measurement of submaxillary gland functionalism changes based on Gammagraphy | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lluis Orozco, MD | Contact | 600 421 095 | lluis.orozco@itrt.es | |
| Roberto Soler Rich, MD | Contact | 609 525 263 | robert.soler@itrt.es |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Terapia Regenerativa Tissular | Barcelona | 08022 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single arm due to not alternative treatment exist
Not provided
Not provided
Not provided
Not provided
|