Wound HealingNCT07372404
Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation
A study testing Topical treatment in people with Wound Healing, run by Linio Biotech Oy at 1 site in Finland.
Trial summary
This study will evaluate the effect of an allogeneic adipose tissue extract on wound healing and scar maturation. Thirty adult patients scheduled for skin graft surgery will be enrolled. Each patient will have two skin graft donor sites harvested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Topical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 11 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wound of at least 10 cm3 with an indication of skin graft surgery (two skin grafts harvested and used)
- Adult (age 18 years or more)
- Able and willing to give informed consent
- Reasonably accessible to the study clinic and compliant to wound treatment
Who cannot join
- Known allergy to any of the preparation used in the study (Tience)
- Systemic cancer (does not include carcinoma in situ of the cervix or local skin cancers such as basiloma)
- Pregnancy or nursing
- Those who withhold consent
- Active infection on the receptor site, donor site or sepsis
- Any other serious disease likely to compromise the outcome of the trial, such as critical renal disease (creatinine greater than 300 mmol/l)
- Those living at such a distance from the clinic as would make frequent assessment visits inappropriately expensive and/or impractical.
- Those with conditions, which tend to limit a patient´s ability or willingness to restrict activities or comply with the instructions during the treatment and follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Allogeneic Human Fat-Derived Extract on Skin Graft Donor Site Wound Healing
This study will evaluate the effect of an allogeneic adipose tissue extract on wound healing and scar maturation. Thirty adult patients scheduled for skin graft surgery will be enrolled. Each patient will have two skin graft donor sites harvested. One skin graft donor site wound will be treated topically with the adipose tissue extract, applied immediately after harvesting and reapplied on Day 3, while the other skin graft donor site wound will receive standard care. The main outcome is the time to complete epithelialization of the wound, as confirmed by investigators and independent reviewers. Secondary measures include wound characteristics, scar formation and scar quality, and monitoring of adverse events, such as wound deterioration.
Read the detailed description
Cell-free preparate of human adipose tissue is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. The tissue product provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue.
- Conditions
- Wound Healing
- Being tested
- Topical treatment
- Keywords
- allogeneic tissue product, adipose-derived tissue, skin graft donor site, split-thickness skin graft, epithelialization, wound assessment, scar quality, scar maturation, scar thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical treatmentProcedure or surgery
The adipose tissue extract will be applied topically to one skin graft donor site wound immediately after harvesting and reapplied on Day 3. The other donor site will receives standard wound care according to hospital protocol, without application of adipose tissue extract. Wounds will be photographed and assessed on Days 3, 7, 14, and 60. Study participants and independent evaluators are blinded to treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| Adipose tissue extract treatment | Experimental | Study participants will have two skin graft donor sites harvested. One donor site will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3. The other skin graft donor site wound will receive standard of care, following the hospital's Current Care Guidelines. Receives: Procedure: Topical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
The primary efficacy end point will the wound healing time during this study period, in days. Healing will be defined as complete epithelialization (mm paper, photographs), confirmed by an investigator and independent evaluators. The comparison will be made between the donor site treated with allogeneic adipose tissue extract (ATE) and the untreated donor site (standard care) within the same participant.
Measured: Day 3, Day 7, Day 14, Day 60
The number adverse events, including deterioration of the wounds during the study.
The primary safety end points will be the number adverse events, including deterioration of the wounds during the study.
- Adverse events, including deterioration of wounds
- Severe wound complications (necrosis, infection)
Measured: Day 3, Day 7, Day 14, Day 60
Clinical evaluation
The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation
Measured: Day 3, Day 7, Day 14
Clinical imaging
Digital photographs will be taken to document the progression of wound healing. One or two blinded plastic surgeons, with no conflicts of interest, will evaluate the donor site wounds and scars based on these photographs. They will assess and compare the donor sites treated with allogeneic adipose tissue extract (ATE) and those treated with standard care, as well as the resulting scars, using the photographic documentation.
Measured: Post op, Day 3, Day 7, Day 14, and Day 60
Clinical evaluation
Scar scaling, modified Vancouver burn scale consists of six items. All items are scored on a scale ranging from 1 ('like normal skin') to 3 ('worst scar imaginable'). • Vascularity category: pale, pink, red, normal • Pigmentation category: hypo, hyper, normal • Height: plane, depressed, elevated • Matte vs. shine: shine, matte • Contour: forms part of the adjacent skin, small indentation or invagination • Texture: normal, barely palpable, rough, indented
Measured: Day 60
Secondary outcomes (3)
Pain Intensity Measure
VAS Visual analogue scale (0-10 points)
Measured: Day 3, Day 7, Day 14
Clinical evaluation
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool that evaluates scars from both the clinician's and the patient's perspectives. The POSAS scale includes seven parameters-each rated from 1 (normal skin) to 10 (worst scar imaginable). The Scale assesses pain, itching, color, stiffness, thickness, irregularity, and overall impression.
Measured: Day 60
Fever (only symptomatic patients)
Temperature (°C)
Measured: Day 3, Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start11 Apr 2023
- Primary completion24 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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. Each participant will have two skin graft donor sites harvested. One donor site wound will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3, while the other donor site wound will receive standard care. Photographic documentation and clinical evaluation of the donor site wounds will be performed on Days 3, 7, 14, and 60 to monitor wound healing progression. Study participants and independent evaluators are blinded to treatment allocation.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linio Biotech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Nova, Central Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372404
- Sponsor's protocol ID
- CT-003
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allogeneic Human Fat-Derived Extract on Skin Graft Donor Site Wound Healing
- ClinicalTrials.gov ID
- NCT07372404
- Acronym / sponsor ID
- CT-003
- Conditions
- Wound Healing
- Keywords
- allogeneic tissue product, adipose-derived tissue, skin graft donor site, split-thickness skin graft, epithelialization, wound assessment, scar quality, scar maturation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Linio Biotech OyIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Nova, Central Finland
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (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.
This study will evaluate the effect of an allogeneic adipose tissue extract on wound healing and scar maturation. Thirty adult patients scheduled for skin graft surgery will be enrolled. Each patient will have two skin graft donor sites harvested. One skin graft donor site wound will be treated topically with the adipose tissue extract, applied immediately after harvesting and reapplied on Day 3, while the other skin graft donor site wound will receive standard care. The main outcome is the time to complete epithelialization of the wound, as confirmed by investigators and independent reviewers. Secondary measures include wound characteristics, scar formation and scar quality, and monitoring of adverse events, such as wound deterioration.
Detailed description
Cell-free preparate of human adipose tissue is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. The tissue product provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue.
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. Each participant will have two skin graft donor sites harvested. One donor site wound will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3, while the other donor site wound will receive standard care. Photographic documentation and clinical evaluation of the donor site wounds will be performed on Days 3, 7, 14, and 60 to monitor wound healing progression. Study participants and independent evaluators are blinded to treatment allocation.
| Arm | Type | Receives |
|---|---|---|
| Adipose tissue extract treatment | Experimental | Procedure: Topical treatmentStudy participants will have two skin graft donor sites harvested. One donor site will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3. The other skin graft donor site wound will receive standard of care, following the hospital's Current Care Guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Wound of at least 10 cm3 with an indication of skin graft surgery (two skin grafts harvested and used)
- Adult (age 18 years or more)
- Able and willing to give informed consent
- Reasonably accessible to the study clinic and compliant to wound treatment
Key exclusion criteria (8 listed)
- Known allergy to any of the preparation used in the study (Tience)
- Systemic cancer (does not include carcinoma in situ of the cervix or local skin cancers such as basiloma)
- Pregnancy or nursing
- Those who withhold consent
- Active infection on the receptor site, donor site or sepsis
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 |
|---|---|---|
| Topical treatmentThe adipose tissue extract will be applied topically to one skin graft donor site wound immediately after harvesting and reapplied on Day 3. The other donor site will receives standard wound care according to hospital protocol, without application of adipose tissue extract. Wounds will be photographed and assessed on Days 3, 7, 14, and 60. Study participants and independent evaluators are blinded to treatment allocation. | Procedure or surgery | Adipose tissue extract treatment |
Primary outcome
Clinical evaluation
Time frame: Day 3, Day 7, Day 14, Day 60
The primary efficacy end point will the wound healing time during this study period, in days. Healing will be defined as complete epithelialization (mm paper, photographs), confirmed by an investigator and independent evaluators. The comparison will be made between the donor site treated with allogeneic adipose tissue extract (ATE) and the untreated donor site (standard care) within the same participant.
The number adverse events, including deterioration of the wounds during the study.
Time frame: Day 3, Day 7, Day 14, Day 60
The primary safety end points will be the number adverse events, including deterioration of the wounds during the study. * Adverse events, including deterioration of wounds * Severe wound complications (necrosis, infection)
Clinical evaluation
Time frame: Day 3, Day 7, Day 14
The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation
Clinical imaging
Time frame: Post op, Day 3, Day 7, Day 14, and Day 60
Digital photographs will be taken to document the progression of wound healing. One or two blinded plastic surgeons, with no conflicts of interest, will evaluate the donor site wounds and scars based on these photographs. They will assess and compare the donor sites treated with allogeneic adipose tissue extract (ATE) and those treated with standard care, as well as the resulting scars, using the photographic documentation.
Clinical evaluation
Time frame: Day 60
Scar scaling, modified Vancouver burn scale consists of six items. All items are scored on a scale ranging from 1 ('like normal skin') to 3 ('worst scar imaginable'). • Vascularity category: pale, pink, red, normal • Pigmentation category: hypo, hyper, normal • Height: plane, depressed, elevated • Matte vs. shine: shine, matte • Contour: forms part of the adjacent skin, small indentation or invagination • Texture: normal, barely palpable, rough, indented
3 secondary outcomes
Pain Intensity Measure
Time frame: Day 3, Day 7, Day 14
Clinical evaluation
Time frame: Day 60
Fever (only symptomatic patients)
Time frame: Day 3, Day 7, and Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Topical treatment in people with Wound Healing, 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 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical evaluation (time frame: Day 3, Day 7, Day 14, Day 60). The study lists 5 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 25 Jun 2026.