NCT01739530已完成1 期
Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers
Anterogen Co., Ltd.2 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2009年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Adverse events
研究概览
简要总结
Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male, 19 years of age or older
- •volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
- •informed consent form signed
排除标准
- •volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
- •volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
- •volunteers who have tattoo or scar which disturb assessment of study at injection site
- •volunteers who have Creutzfeldt Jacobs disease or related disease or family history
- •volunteers who have allergy to bovine-derived materials
- •volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
- •volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
- •volunteers who have a clinically relevant history of abuse of alcohol or drugs
- •volunteers who are considered not suitable for the study by investigator
- •volunteers who have history of surgery for malignant cancer in the past 5 years
- •volunteers who have congenital or acquired immunodeficiency syndrome
- •volunteers who have horrible anemia or thrombopenia
- •volunteers who have chronic disease such cardiovascular,renal and respirometer disease
- •volunteers who were immunosuppressed by disease (ex: chronic heart failure)
- •volunteers who were immunodepressed by treatment of medication
- •volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
- •volunteers who have abnormal rage of CD4/CD8 ratio
研究组 & 干预措施
Repaircell
Experimental
allogenic differentiated adipocyte
干预措施: Repaircell (Biological)
结局指标
主要结局
Number of Adverse events
时间窗: week 8
Evaluate the safety at week 8 whether any kind of Adverse event occurs
次要结局
- Immunological response II(week 8)
- Immunological response I(change from baseline CD4/CD8 ratio at week 8)
研究者
研究点 (2)
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