Safety and efficacy of cultured adipose-derived stem cells for breast-reconstruction after breast conserving surgery with radiation (CABCR)

未提供0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年3月5日

试验速览

暂无简介。

•Patients who meet all of the following conditions:
•Female, age 20 years and older
•Primary breast cancer in one side
•Anticipate reconstruction for breast deformity after breast-conserving surgery followed by radiation therapy
•Last surgery for breast cancer more than 1 year prior to enrollment
•No metastasis, residual or local recurrence, and no evidence of recurrence of cancer
•Available adipose tissue collection with inhalation technique
•Signed written informed consent

•Patients who meet any of the following conditions:
•Not enough adipose tissue collection
•Not controlled infectious diseases
•Evidence of infection in treatment target area and adipose tissue collection site
•History of breast augmentation in affected side
•Presence of any other known malignancy or metastasis
•Use of anticancer, immunosuppressant, anticoagulant or antiplatelet agents during this research, from first adipose tissue collection to 18-month follow-up
•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
•Considered by investigator due to any other severe condition such as cardiac, lung, liver, kidney, auto-immune, not-controlled diabetes, or drug allergy
•Pregnant or breast-feeding
•Smoker or unavailable to quit smoking during this research, from first adipose tissue collection to 18-month follow-up
•Not appropriate or not consent obtained for general anesthesia
•Lack of cooperation with the procedures designated for this research
•Considered as inappropriate for this research for any reason by investigators

Number and Grade of adverse events

时间窗: from day 0 to 18 months follow-up

Number and Grade (CTCAR v5.0-JCOG) of adverse events related to this research

发起方

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