Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
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|ClinicalTrials.gov Identifier: NCT03743155|
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia Due to Radiotherapy||Biological: mesenchymal cells||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single arm due to not alternative treatment exist|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 2021|
Experimental: treatment with mesenchymal stem cells
xerostomy using mesenchymal stem cells adult autologous bone marrow
Biological: mesenchymal cells
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
- 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
- AEs and SAEs [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743155
|Contact: Lluis Orozco, MD||600 421 email@example.com|
|Contact: Roberto Soler Rich, MD||609 525 firstname.lastname@example.org|
|Institut de Terapia Regenerativa Tissular|
|Barcelona, Spain, 08022|