EUCTR2018-001720-19-ES
Active, not recruiting
Phase 1
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 - Xerostomia
Institut de Terapia Regenerativa Tissular S.L. (ITRT)0 sites10 target enrollmentNovember 23, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Xerostomia post radiotherapy
- Sponsor
- Institut de Terapia Regenerativa Tissular S.L. (ITRT)
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients from 18 to 75 years old of both sexes.
- •2\. Biochemical analysis without significant alterations which could contraindicate the treatment.
- •3\. Bilateral radiotherapy of the previous neck due to neoplasia in states T1\-T2 and N0, N1 and N2a.
- •4\. 2 years of follow\-up without recurrence.
- •5\. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0\.05\-0\.20 ml / min.
- •6\. Grade 1\-3 xerostomy as assessed by the grading scale.
- •7\. The patient is able to understand the nature of the study.
- •8\. Written informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\. Participation in another clinical trial in the 3 months prior to his/her inclusion.
- •2\. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
- •3\. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
- •4\. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
- •5\. Xerogenic medication in progress.
- •6\. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
- •7\. Local infection.
- •8\. Pregnancy or pregnancy planned within the next 2 years.
- •9\. Breastfeeding.
- •10\. Treatment with anticoagulants (not interruptible in MO or application).
Outcomes
Primary Outcomes
Not specified
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