JPRN-jRCT1090220159已完成Unknown
Study of Breast Reconstruction with Adipose tissue-derived mesenchymal stem cells (ADSCs) in the Treatment of Patients with Breast Deformities Post-breast Conservation Therapy
Rie Yamashita0 个研究点目标入组 5 人开始时间: 2014年1月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 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
- >= 至 ot applicable（—）
- 性别
- Female
入选标准
- •(1) Female with Breast Deformities Post-breast Conservation Therapy
- •(2) Surgical operation, endoscopic surgery or segmental mastectomy
- •(3)Clean surgical margins
- •(4)Presence of sufficient fat volume to liposuction
- •(5)No use of an artificial breast
- •(6)No recurrence of cancer and cancer metastasis 12 months prior to enrollment
- •(7)No evidence of recurrence of cancer in based on Mammogram or MRI prior to enrollment
- •(8)No history of cancer targeted chemotherapy (except estrogen replacement therapy) in the 12 months preceding enrollment.
- •(9)A minimum of 1cm soft tissue is available between skin and breast
- •(10)A minimum of 2/3 of the breast is remaining post breast conservation therapy.
- •(11)No continuous adhesions of skin to bone > 3cm in diameter
- •(12)The patient understand the clinical studies, she wishes to treatment and her consent is obtained
排除标准
- •(1)Presence or history of any other known malignancy within 5 years. Possibility of malignant tumors by checking examination.
- •(2)Current use of anti-cancer therapies or immunosuppressant
- •(3)Presence of infection disease
- •(4)Fever (above 38.5 degree)
- •(5)Presence of serious complications (such as poor control high blood pressure and diabetes, heart disease, lung disease, liver disease, kidney disease, or bleeding tendency )
- •(6)History of autoimmune disease
- •(7)History of keloid constitution
- •(8)Chronic use ( > 7 consecutive days) anticoagulants or NSAIDs within 15 days prior to enrollment.
- •(9)Life expectancy <= 2 years
- •(10)30 < Body Mass Index (BMI) < 18.5
- •(11)History of drug hypersensitivity
- •(12)Pregnancy, breastfeeding and/or possibility of pregnant
- •(13)Other, If the doctor (investigator) has to be inappropriate
研究者
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