Safety of Cell-free Adipose Tissue Product in Healthy Volunteers (NCT05518084) | Clinical Trial Compass
CompletedNot Applicable
Safety of Cell-free Adipose Tissue Product in Healthy Volunteers
Finland38 participantsStarted 2022-08-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute local reactions 20 minutes after injection
Timeframe: Day 0
2
Acute and mid-term adverse events, incl severe adverse events
Timeframe: Day 0-7, Day 30, and Day 60
3
Acute and mid-term adverse events, incl severe adverse events
Timeframe: Day 90
4
Acute and mid-term adverse events, incl severe adverse events