KCT0006783招募中未知
An open label, single-center, phase 1 study to evaluate the safety of Allogeneic bone marrow derived mesenchymal stem cell in patients with Chronic Kidney Disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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 79?(Year)（—）
- 性别
- All
入选标准
- •1. Male or female between the ages of 19 and 79
- •2. Those diagnosed with CKD stage 3b or 4 [eGFR 15 - 44 ml/min/1.73 m2] within 1 year before screening
- •3. Those who voluntarily participated in the clinical trial and signed the Informed consent form
排除标准
- •1. Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
- •2. Those with the following medical history/comorbidities
- •A. Gentamicin hypersensitivity reaction
- •B. Solid cancer or malignant blood disease within 5 years prior to screening
- •C. Clinically significant cognitive disorder, dementia or psychiatric disorder
- •D. Alcohol or drug abuse
- •E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.)
- •G. Systemic autoimmune disease
- •3. Those whose test results fall under the following at the screening visit
- •A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive
- •B. Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg)
- •C. AST and ALT = upper limit of normal x 3.0
- •D. Total bilirubin = upper limit of normal x 1.5
- •4. At screening, those who have the following treatment history
- •A. Those who are being treated for severe systemic infection
- •B. Those who have been treated with immunosuppressant within 28 days prior to screening
- •5. Those with a history of renal transplantation
- •6. Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period
- •7. Pregnant, lactating, or planning during clinical trials
- •8. Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period
- •9. Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator
- •10. Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures
- •11. Those who have or are planning to administer other cell therapy products
- •12. Those who are judged by the investigator to be inappropriate to participate in this clinical trial
研究者
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