Safety of Cell-free Adipose Tissue Product in Healthy Volunteers (SAFETY)

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

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Other: Liponovo tissue product

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Terveystalo, Ruoholahti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• smoking
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute local reactions 20 minutes after injection	Examination and structured interview 20 minutes after injection by the investigator	Day 0
Acute and mid-term adverse events, incl severe adverse events	E-dairy filled out by the participants	Day 0-7, Day 30, and Day 60
Acute and mid-term adverse events, incl severe adverse events	Evaluation and structured interviews by the investigator	Day 90
Acute and mid-term adverse events, incl severe adverse events	Structured telephone interview by study nurse	Day 7 and Day 9
Delayed allergic reactions	Participant's e-dairy	Day 0-7, Day 30, and Day 60
Delayed allergic reactions	Telephone interviews by the study nurse	Day 2, and Day 7

Collaborators and Investigators

• Sponsor: Linio Biotech Oy
• Collaborators: Clinius Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No