JPRN-jRCT2053230136招募中1 期
Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for dilated cardiomyopathy
Miyagawa Shigeru0 个研究点目标入组 4 人开始时间: 2023年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) dilated cardiomyopathy
- •2) NYHA class 3,4
- •3) Patients who can not expect symptomatic improvement with standarid treatment for taget disease.To be recognized by the third party committee with experts.
- •4) Patients who have not seen improvement in cardiac function more than 3 months after standard surgical treatment and who are at risk of worsening heart failure
- •5) Ejecion franction<40%
- •6) Patients who can obtain written consent from the subject to participate in the clinical trial.
- •7) Patients who can continue to visit the study site for 52 weeks after transplantation
排除标准
- •1) Autoimmune disease
- •2) Allergic or hypersensitive to the immunosuppressant
- •3) Severe infection
- •4) Persistent shock due to worsening heart failure
- •5) Irreversible organ failure other than heart
- •6) Malignancy
- •7) Pregnancy
- •8) Alcoholic or drug addiction in recent six months
- •9) Allergies or hypersensitivity to animals from which raw materials used
- •10) Severe pulmonary hypertension
- •11) Within 6 months after participating in the clinical trial
- •12) Patients deemed unsuitable as subjects
研究者
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