NCT05518084

Safety of Cell-free Adipose Tissue Product in Healthy Volunteers

Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Linio Biotech Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
OTHER	Liponovo tissue product	Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. The single injection and a 23G/30mm needle are used. The amount of the injected investiogational products is 4,5 ml for both dorsal forearms (together 4,5ml x2 = 9ml / test subject). The product is always injected in the proximal third of the forearm, into a standardized a quarter circle with a radius of 30mm. Both injections are performed with covered syringe to ensure the double-blinding. After the injection, test subjects get a cold on the injection sites to reduce the bruising.

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-12-01
• Completion: 2023-02-01
• First posted: 2022-08-26
• Last updated: 2026-01-28

Locations

1 site across 1 country: Finland