Last reviewed · How we verify
Safety of Cell-free Adipose Tissue Product in Healthy Volunteers (SAFETY)
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.
Details
| Lead sponsor | Linio Biotech Oy |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 38 |
| Start date | Wed Aug 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Safety Issues
Interventions
- Liponovo tissue product
Countries
Finland