Safety IssuesSAFETYNCT05518084
Safety of Cell-free Adipose Tissue Product in Healthy Volunteers
A study testing Liponovo tissue product in people with Safety Issues, run by Linio Biotech Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Liponovo tissue product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFinland
- Study dates
- 24 Aug 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers
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
- Being tested
- Liponovo tissue product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Liponovo tissue product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute local reactions 20 minutes after injection
Examination and structured interview 20 minutes after injection by the investigator
Measured: Day 0
Acute and mid-term adverse events, incl severe adverse events
E-dairy filled out by the participants
Measured: 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
Measured: Day 90
Acute and mid-term adverse events, incl severe adverse events
Structured telephone interview by study nurse
Measured: Day 7 and Day 9
Delayed allergic reactions
Participant's e-dairy
Measured: Day 0-7, Day 30, and Day 60
Delayed allergic reactions
Telephone interviews by the study nurse
Measured: Day 2, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start24 Aug 2022
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linio Biotech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518084
- Sponsor's protocol ID
- CT-001
- Acronym
- SAFETY
- Status last verified
- Jan 2026
- First submitted
- 24 Aug 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05518084
- Acronym / sponsor ID
- SAFETY / CT-001
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Linio Biotech OyIndustry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liponovo tissue product and Ringer Acetat injections | Experimental | Other: Liponovo tissue productInvestigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liponovo tissue productInvestigational 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. | Other | Liponovo tissue product and Ringer Acetat injections |
Primary outcome
Acute local reactions 20 minutes after injection
Time frame: Day 0
Examination and structured interview 20 minutes after injection by the investigator
Acute and mid-term adverse events, incl severe adverse events
Time frame: Day 0-7, Day 30, and Day 60
E-dairy filled out by the participants
Acute and mid-term adverse events, incl severe adverse events
Time frame: Day 90
Evaluation and structured interviews by the investigator
Acute and mid-term adverse events, incl severe adverse events
Time frame: Day 7 and Day 9
Structured telephone interview by study nurse
Delayed allergic reactions
Time frame: Day 0-7, Day 30, and Day 60
Participant's e-dairy
Delayed allergic reactions
Time frame: Day 2, and Day 7
Telephone interviews by the study nurse
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liponovo tissue product in people with Safety Issues, run by Linio Biotech Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute local reactions 20 minutes after injection (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.