Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
NCT03743155 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2018-11-16
Summary
Phase II not controlled, open-label, prospective, single center clinical trial
Conditions
- Xerostomia Due to Radiotherapy
Interventions
- 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
Sponsors & Collaborators
-
Institut de Terapia Regenerativa Tissular
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-15
- Primary Completion
- 2019-05-30
- Completion
- 2021-05-30
Countries
- Spain
Study Locations
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