JPRN-jRCTb030230126暂停Unknown
Safety and efficacy of cultured adipose-derived stem cells for breast-reconstruction after breast conserving surgery with radiation - CABCR
Komuro Yuzou0 个研究点目标入组 5 人开始时间: 2023年6月8日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 暂停
- 发起方
- 入组人数
- 5
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
- >= 20age old 至 ot applicable(—)
- 性别
- Female
入选标准
- •Patients who meet all of the following conditions:
- •1) Female, age 20 years and older
- •2) Primary breast cancer in one side
- •3) Anticipate reconstruction for breast deformity after breast-conserving surgery followed by radiation therapy
- •4) Last surgery for breast cancer more than 1 year prior to enrollment
- •5) No metastasis, residual or local recurrence, and no evidence of recurrence of cancer
- •6) Available adipose tissue collection with inhalation technique
- •7) Signed written informed consent
排除标准
- •Patients who meet any of the following conditions:
- •1) Not enough adipose tissue collection
- •2) Not controlled infectious diseases
- •3) Evidence of infection in treatment target area and adipose tissue collection site
- •4) History of breast augmentation in affected side
- •5) Presence of any other known malignancy or metastasis
- •6) Use of anticancer, immunosuppressant, anticoagulant or antiplatelet agents during this research, from first adipose tissue collection to 18-month follow-up
- •7) Surgery or radiation therapy in treatment target area and adipose tissue collection site during this research, from first adipose tissue collection to 18-month follow-up
- •8) Considered by investigator due to any other severe condition such as cardiac, lung, liver, kidney, auto-immune, not-controlled diabetes, or drug allergy
- •9) Pregnant or breast-feeding
- •10) Smoker or unavailable to quit smoking during this research, from first adipose tissue collection to 18-month follow-up
- •11) Not appropriate or not consent obtained for general anesthesia
- •12) Lack of cooperation with the procedures designated for this research
- •13) Considered as inappropriate for this research for any reason by investigators
研究者
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