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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Acute local reactions 20 minutes after injection
Timeframe: Day 0
Acute and mid-term adverse events, incl severe adverse events
Timeframe: Day 0-7, Day 30, and Day 60
Acute and mid-term adverse events, incl severe adverse events
Timeframe: Day 90
Acute and mid-term adverse events, incl severe adverse events
Timeframe: Day 7 and Day 9
Delayed allergic reactions
Timeframe: Day 0-7, Day 30, and Day 60
Delayed allergic reactions
Timeframe: Day 2, and Day 7