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

Linio Biotech Oy

Status: Completed

Conditions: Safety Issues

Treatments: Other: Liponovo tissue product

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518084

CT-001

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Liponovo tissue product and Ringer Acetat injections

Experimental group

Description:

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

Treatment:

Other: Liponovo tissue product