NCT03743155

Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Institut de Terapia Regenerativa Tissular · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II not controlled, open-label, prospective, single center clinical trial

Detailed description

* 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).

Conditions

• Xerostomia Due to Radiotherapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-15
• Primary completion: 2019-05-30
• Completion: 2021-05-30
• First posted: 2018-11-16
• Last updated: 2018-11-16

Locations

1 site across 1 country: Spain