JPRN-jRCTb070190057进行中（未招募）1 期
Phase 1 Clinical Study of Cell Therapy with Effective-Mononuclear Cells (E-MNC) for Radiogenic Xerostomia (First-in-human Study) - FIH study on E-MNC therapy for radiogenic xerostomia
Asahina Izumi0 个研究点目标入组 6 人开始时间: 2020年3月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Patients who are suffering form sever xerostomia caused by the radiotherapy for head and neck cancer.
- •2. Patients who have no recurrence of head and neck cancer more than 5 years after treatment.
- •3. Patients who complain the xerostomia and whose saliva flow rate is in the range of less than 10ml/10min.
- •4. Patients who are detected the salivary gland atrophy by CT examination.
排除标准
- •1. Hemoglobin concentration in peripheral blood
- •1) blood collection within 200ml
- •male: less than 12.5g/dl of hemoglobin concentration
- •femal: less than 12.0g/dl of hemoglobin concentration
- •2) blood collection with 200ml and over (within 240ml)
- •male: less than 13.0g/dl of hemoglobin concentration
- •femal: less than 12.5g/dl of hemoglobin concentration
- •2. Patients who had got salivary gland tumor as a primary disease.
- •3. Patients who have any cancer and sepsis.
- •4. Patients who suffer from severe endocrine metabolic disease and autoimmune disease.
- •5. Patients who are posiitive of sphilis, HBV-antigen, HCV-antigen, HTLV-1-antibody and HIV-antibody.
- •6. Patients who are judged as improper to join in this study by the principal investigator or co-investigators.
研究者
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