NCT00616135已完成4 期
A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study.
Cytori Therapeutics9 个研究点 分布在 4 个国家目标入组 71 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 9
- 主要终点
- Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
研究概览
简要总结
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
- •Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
- •Clean surgical margins
- •No prosthesis in breast(s) to undergo treatment
- •Ability to undergo lipoaspiration
- •Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
- •No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
- •Objective signs of mild breast damage post Breast Conservation Therapy
- •Type I Cosmetic Sequelae Classification
- •A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
- •A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
- •No continuous adhesion of skin to bone >3 cm in diameter
- •The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)
排除标准
- •History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])
- •History of connective, metabolic or atrophic skin disease
- •History of keloid scarring
- •Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
- •Life expectancy ≤ 2 years
- •Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
- •Presence of any other known malignancy
- •Body Mass Index (BMI) >30
- •Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI >5 compared to baseline
- •Presence of contraindications to MRI
结局指标
主要结局
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
时间窗: 12 months
次要结局
- Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline.(6 months and 12 months)
研究者
研究点 (9)
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