KCT0003417已完成未知
An open, single-center, phase 1 study to evaluate safety of hypoxic preconditioned allogeneic bone marrow derived mesenchymal stem cell aiming to prevent acute kidney injury due to renal ischemia-reperfusion injury
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
o clinically or statistically significant deterioration in renal function was observed except for an increase in serum creatinine at 30 days after injection. Acute kidney injury due to ischemia-reperfusion injury is considered risk factors such as diabetes, hypertension, and old age. Most of the subjects in this clinical trial did not have risk factors for acute kidney injury, and their renal function was normal before injection. It may not have happened. To determine the effectiveness of Cellgram-AKI injection, it is thought that a study targeting the high-risk group for acute renal injury is needed.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1) Patients =18 and <80 years of age who temporarily block the blood flow of the kidney and undergo partial renal resection for kidney tumors
- •2) A patient with a primary renal tumor with a diameter of 2 cm or less, clinical stage T1aN0M0 (without surrounding tissue or lymph node involvement or metastasis)
排除标准
- •1) Patients with a history of blood diseases (malignant blood diseases: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma)
- •2) Serum AST / ALT level >3 × upper limit of normal
- •3) Patients with a history of hypersensitivity against a gentamycin
- •4) Patients positive for pathogenic microorganisms (HIV, HBV, HCV, Syphilis)
- •5) Patients unable to compliance with protocol and follow-up
- •6) Patients with a history of substance abuse in the past year
- •7) Those who participated in other clinical trials in the past 30 days before registration.
- •8) Patients to be inappropriate to participate in the study according to the investigator
- •9) Uncontrolled hypertension or hypotension (systolic blood pressure >170 or <90 mmHg, diastolic pressure >100 or <50 mmHg)
- •10) Those who being treated for severe infectious disease
- •11) Pregnant women, lactating women and those who disagree with contraception
- •12) Those who suffered or sufferring another malignant tumors excluding primary kidney tumors
- •13) Patients with a single kidney
- •14) patients with chronic kidney disease V (glomerular filtration rate <15 ml / min per 1.73 m² or during dialysis)
研究者
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