EUCTR2018-001720-19-ES进行中（未招募）1 期
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 个研究点目标入组 10 人开始时间: 2018年11月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •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).
- •11. Any other illness or condition that is grounds for exclusion for the investigator.
研究者
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