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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Measurement of submaxillary gland functionalism changes based on Gammagraphy
研究概览
简要总结
Phase II not controlled, open-label, prospective, single center clinical trial
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 75 years old of both sexes.
- •Biochemical analysis without significant alterations which could contraindicate the treatment.
- •Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
- •2 years of follow-up without recurrence.
- •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.
- •Grade 1-3 xerostomy as assessed by the grading scale.
- •The patient is able to understand the nature of the study.
- •Written informed consent of the patient
排除标准
- •Participation in another clinical trial in the 3 months prior to his/her inclusion.
- •Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
- •Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
- •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.
- •Xerogenic medication in progress.
- •Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
- •Local infection.
- •Pregnancy or pregnancy planned within the next 2 years.
- •Breastfeeding.
- •Treatment with anticoagulants (not interruptible in MO or application).
- •Any other illness or condition that is grounds for exclusion for the investigator.
研究组 & 干预措施
treatment with mesenchymal stem cells
xerostomy using mesenchymal stem cells adult autologous bone marrow
干预措施: mesenchymal cells (Biological)
结局指标
主要结局
Measurement of submaxillary gland functionalism changes based on Gammagraphy
时间窗: 24 months
Measurement of submaxillary gland functionalism changes based on Gammagraphy
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
时间窗: 24 months
Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)
Sialometry results
时间窗: 24 months
Absolute and relative change in the volume of saliva (ml / min) submaxillary
Changes in the characteristics and degree of discomfort of xerostomia.
时间窗: 24 months
Absolute and relative change of the score of the EVA Questionnaire
Restoration of the glandular structure.
时间窗: 24 months
Changes in the glandular structure (volume) (MRI with contrast)
次要结局
- AEs and SAEs(24 months)