A Phase 2 interventional study of mesenchymal cells in Xerostomia Due to Radiotherapy, sponsored by Institut de Terapia Regenerativa Tissular. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Institut de Terapia Regenerativa Tissular · Phase 2, Interventional, and Treatment
Phase II not controlled, open-label, prospective, single center clinical trial
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's planned enrollment of 10 is below the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Institut de Terapia Regenerativa Tissular is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2018; primary completion for May 2019, 5 months later.
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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Institut de Terapia Regenerativa Tissular