KCT0006001招募中未知
A phase 1/2a clinical trial to evaluate the safety and efficacy of allogeneic adipose tissue-derived mesenchymal stem cell clusters in patients with critical limb ischemia
S.Biomedics0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- •1) Adults aged 19 or older
- •2) A person diagnosed with critical limb ischemia due to peripheral artery stenosis or obstructive disease (Rutherford category 4, 5, 6)
- •3) Patients with critical limb ischemia where symptoms do not improve even after medication treatment for more than 3 months
- •4) Persons who voluntarily agreed to participate in this clinical study
排除标准
- •1) Persons whose life expectancy is less than 6 months
- •2) Patients who underwent surgery and interventional procedures (percutaneous vascular intervention, vascular reconstruction, etc.) in the same disease within 3 months of screening
- •3) Patients with indications of interventional procedure or surgery
- •4) Patients with a history of administration of other cell therapy products
- •5) Persons who have received systemic immunosuppression treatment within 3 months of screening
- •6) Persons with a history of a malignant tumor within 5 years of screening
- •(However, non-metastatic basal cell skin carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix that does not recur for at least 1 year before the registration are excluded)
- •7) Persons with a hematologic disease with major bleeding or bleeding predisposition within 3 months of screening
- •8) Women who are pregnant, breastfeeding, or planning to become pregnant during the clinical study period, or men and women of childbearing potential who do not use medically acceptable birth control
- •9) Persons who participated in another clinical study within 3 months of screening
- •10) Persons who were administered prohibited concomitant medications related to this clinical study
- •11) Persons with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than twice the normal upper limit at the time of screening
- •12) Persons identified with estimated glomerular filtration rate (eGFR) levels < 30 mL/min/1.73 m^2 at the time of screening
- •13) Persons with a history of allergies or hypersensitivity to the investigational product or its components
- •14) Persons who are judged to be inadequate to participate in clinical study by other investigators
研究者
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