A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Volume retention
研究概览
简要总结
This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.
详细描述
Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties.
The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a result of the aging process as well as some pathological diseases. It can be corrected via autologous fat transfer but usually the majority of the grafted cells will die after 6-12 months. Several publications demonstrate that the addition of SVF cells to the graft may enhance the graft survival.
This double blind, randomized study aims to demonstrated the efficacy of Antria Cell Preparation Process in autologous facial fat grafting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male, Age 18 to 70 years old
- •Subjects that are eligible for liposuction and facial fat grafting procedures for cosmetic purposes and facial atrophy.
- •Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required.
- •Inframalar Atrophy Assessment Scale of 2 to 4
- •Facial volume defect range: 2 to 10 mL
- •Body Mass Index (BMI) between and including 22 and 29
- •Able to understand and provide written and verbal informed consent
- •Fitzpatrick Scale 1 to 6
排除标准
- •Currently taking or have taken None Steroid Anti-inflammatory Drugs (NSAIDs) within last two weeks or corticosteroids within the last six weeks prior to screening
- •Diagnosis of any of the following medical conditions:
- •Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)
- •Active infection
- •Type I or Type II Diabetes
- •Skin/Bone deformities in the face, including scaring or hyperpigmentation within the graft site.
- •Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
- •Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
- •Dermal fillers or facial reconstruction within the past 24 months, Subjects must also refrain from such procedures during the duration of the study.
- •Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems.
- •Subjects with elevated kidney and/or liver functions
- •Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase risk for subjects.
- •Subjects with life-expectancies less than 9 months
- •Subjects with known collagenase allergies
- •Subjects with idiopathic or drug-induced coagulopathy
- •Pregnant females
- •On radiotherapy or chemotherapy agents
- •Taking strong CYP450 inhibitors
- •Subjects with a history of keloids or hypertrophic scar formations
- •Previous treatment with any synthetic fillers in the inframalar area
研究组 & 干预措施
Stromal Vascular Fraction
Subjects will receive stromal vascular fraction assisted fat transfer.
干预措施: Stromal Vasular Fraction (Biological)
Stromal Vascular Fraction
Subjects will receive stromal vascular fraction assisted fat transfer.
干预措施: Biopsy (Procedure)
Biopsy for Control -regular fat transfer
Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Volume retention
时间窗: 12 months
To demonstrate that SVF administration, in concert with autologous facial fat grafts, is more efficacious, with regards to graft survival, than standard, non-SVF enhanced, autologous facial fat grafts
次要结局
- Changes in the quality of skin(12 months)
- Number of Participants ith autologous facial fat grafts via laboratory results(36 months)