Safety of Cell-free Adipose Tissue Product in Healthy Volunteers

Linio Biotech Oy38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Safety Issues

Interventions

Liponovo tissue productOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Terveystalo, Ruoholahti

Helsinki, Finland

Outcomes

Primary Outcomes

Acute local reactions 20 minutes after injection

Examination and structured interview 20 minutes after injection by the investigator

Time frame: Day 0

Acute and mid-term adverse events, incl severe adverse events

E-dairy filled out by the participants

Time frame: 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

Time frame: Day 90

Acute and mid-term adverse events, incl severe adverse events

Structured telephone interview by study nurse

Time frame: Day 7 and Day 9

Delayed allergic reactions

Participant's e-dairy

Time frame: Day 0-7, Day 30, and Day 60

Delayed allergic reactions

Telephone interviews by the study nurse

Time frame: Day 2, and Day 7

Data from ClinicalTrials.gov

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