A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bates-Jensen Wound Assessment
研究概览
简要总结
This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds
详细描述
This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or Male, Age 18 years or older
- •Subjects that are diagnosed with one or more chronic wounds.
- •Able to understand and provide written and verbal informed consent
排除标准
- •Currently taking or have taken 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 (other than their wound)
- •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
- •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 the risk for subjects.
- •Subjects with life-expectancies less than 12 months
- •Subjects with known collagenase allergies
- •Pregnant females On radiotherapy or chemotherapy agents
研究组 & 干预措施
Antria Cell Preparation Process
Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments
干预措施: Antria Cell Preparation Process (Drug)
结局指标
主要结局
Bates-Jensen Wound Assessment
时间窗: 1 year
This assessment focuses on analysis wounds with regards to the following information: size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding the wound, peripheral tissue edema and induration, granulation tissue, and epithelialization. Each item will be measured on a scale 1-5. A score of 1 will indicate least severe and a score of 5 will indicate the most severe.
次要结局
- Digital Picture of wound(1 year)