KCT0007875撤回未知
An Open-label, Regenerative Medicine Advanced Therapy to Evaluate the Safety and Efficacy of ATORM-C after Single Dose in patients with Chronic Radiation Proctitis
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 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 Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Those who meet all of the following criteria are selected as the subjects for this study.
- •1. Male and female adults 19 years of age or older, in respect to the date of written consent
- •2. Those who received radiation therapy to the pelvis for chemotherapy prior to the screening visit with the last radiation therapy more than 3 months prior to the screening visit
- •3. Those who have been diagnosed with radiation proctitis with confirmed rectal ulcers due to radiation proctitis on screening tests
- •4. Those who understand the purpose of this clinical study, agree to participate in the clinical study, and abide by the restrictions of the protocol in written consent
排除标准
- •Those who meet any of the following criteria are excluded from this study
- •1. Those who have been diagnosed as Crohn’s Disease, Ulcerative Colitis, or Infectious Colitis, prior to the date of screening
- •2. Those diagnosed with colon cancer or rectal cancer prior to the date of screening
- •3. Those with structural abnormalities of the anus [e.g., anal fistula, anal stenosis, etc.], which make equipment such as proctoscopes and endoscopes difficult
- •4. Those who have history of mental illness (alcohol or drug addiction) and is deemed to cause problems regarding safety and confusion in interpretation of results
- •5. Those who test positive for Human Immunodeficiency Virus (HIV) antibody test or hepatitis B surface Antigen (HBsAg), hepatitis C antibody (Anti-Hepatitis C Virus, Anti-HCV) test
- •6. Those with abnormal findings that are not suitable for participation in this study as a result of screening tests (laboratory tests, electrocardiogram tests, vital signs results, etc.)
- •7. Pregnant and lactating women
- •8. Women and men of childbearing potential who plan to become pregnant or do not intend to use appropriate contraceptive methods* during this clinical study
- •*? hormonal contraceptives, ? implantation of intrauterine device or intrauterine system, ? double blocking method with spermicide [use both male condom and occlusion cap (diaphragm or cervical cap)], ? sterilization (vasectomy, bilateral tubal ligation, etc.)
- •9. Those who show hypersensitivity to cow protein and fibrin glue or have a history of anaphylaxis
- •10. Those who participated in other clinical studies or clinical trials within 24 weeks before administration of clinical research drugs
- •11. Those who are deemed as inappropriate to participate in clinical research by other researchers
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