Safety of Cell-free Adipose Tissue Product in Healthy Volunteers

NCT05518084 | Completed DMC

• 1 other identifier: CT-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Liponovo tissue product and Ringer Acetat injections

EXPERIMENTAL

Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis.

Other: Liponovo tissue product

Interventions

Liponovo tissue product OTHER

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.

Liponovo tissue product and Ringer Acetat injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Linio Biotech Oy: lead
• Clinius Ltd: collaborator

Study Sites (1)

Terveystalo, Ruoholahti

Helsinki, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and investigators are blinded to which arm receives placebo vs. investigational product
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are not randomized into different arms. Instead, the side (left or right forearm) receiving the investigational product vs. placebo is randomized for each participant.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 24, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)