Safety Issues
Conditions
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.
Interventions
OTHERLiponovo 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.
Sponsors
Linio Biotech Oy
Clinius Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators are blinded to which arm receives placebo vs. investigational product
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute local reactions 20 minutes after injection | Day 0 | Examination and structured interview 20 minutes after injection by the investigator |
| Acute and mid-term adverse events, incl severe adverse events | Day 0-7, Day 30, and Day 60 | E-dairy filled out by the participants |
| Delayed allergic reactions | Day 0-7, Day 30, and Day 60 | Participant's e-dairy |
Countries
Finland
Outcome results
None listed