Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Acute local reactions 20 minutes after injection
研究概览
简要总结
The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of cell-free adipose tissue product. The safety of the tissue product is to be studied in 40 healthy volunteers. Cell-free tissue product is injected into superficial part of the subcutis with one injection to standardized area. The volume of the injection is 4,5 ml. As the control method, the same size area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.
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 (Participant, Investigator)
盲法说明
Participants and investigators are blinded to which arm receives placebo vs. investigational product
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
- •Adult (age 18 years or more)
- •Healthy skin in the studied area (dorsal forearm, proximal third)
- •Able and willing to give informed consent
- •Reasonably accessible to the study clinic and compliant to follow-up visits
排除标准
- •known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
- •hematologic or other bleeding disorder
- •use of antitrombotic/ anticoagulation medicine
- •autoimmune disease
- •immunosupressive disease or medication
- •cancer or neoplastic disease
- •connective tissue disease
- •diabetes type 1 or 2 or other metabolic diseases
- •pregnancy or nursing
- •sunbathing during last 7 days
- •a skin disease that is or has been symptomatic in the studied area
- •test subjects with previous fat or hyaluronic acid filling under the same area
- •those who withhold consent
- •Use of following medications:
- •Histamine receptor-blockers <7 days before study initiation
- •Topical corticosteroids in test area <7 days before study initiation
- •Topical calsineurin inhibitors <7days before study initiation
- •Longterm (>10days before study initiation) systemic prednisolon >10mg/d
- •Omalitsumabi < 4weeks before study initiation
- •Doksepin < 7 days before study initiation
研究组 & 干预措施
Liponovo tissue product and Ringer Acetat injections
Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis.
干预措施: Liponovo tissue product (Other)
结局指标
主要结局
Acute local reactions 20 minutes after injection
时间窗: Day 0
Examination and structured interview 20 minutes after injection by the investigator
Acute and mid-term adverse events, incl severe adverse events
时间窗: Day 7 and Day 9
Structured telephone interview by study nurse
Delayed allergic reactions
时间窗: Day 2, and Day 7
Telephone interviews by the study nurse
Acute and mid-term adverse events, incl severe adverse events
时间窗: Day 0-7, Day 30, and Day 60
E-dairy filled out by the participants
Acute and mid-term adverse events, incl severe adverse events
时间窗: Day 90
Evaluation and structured interviews by the investigator
Delayed allergic reactions
时间窗: Day 0-7, Day 30, and Day 60
Participant's e-dairy
次要结局
未报告次要终点