Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

June 24, 2026 updated by: Linio Biotech Oy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jenny Lopez, Plastic Surgery Specialist
  • Phone Number: +358 50 479 4588
  • Email: jenny.lopez@hyvaks.fi

Study Locations

  • Finland
    • Finland
      • Jyväskylä, Finland, Finland, 40620
        • Hospital Nova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adipose tissue extract treatment
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.
Procedure: Topical treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 3, Day 7, Day 14, Day 60
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)
Day 3, Day 7, Day 14, Day 60
Clinical evaluation
Time Frame: Day 3, Day 7, Day 14
The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation
Day 3, Day 7, Day 14
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.
Post op, Day 3, Day 7, Day 14, and Day 60
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
Day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity Measure
Time Frame: Day 3, Day 7, Day 14
VAS Visual analogue scale (0-10 points)
Day 3, Day 7, Day 14
Clinical evaluation
Time Frame: Day 60
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.
Day 60
Fever (only symptomatic patients)
Time Frame: Day 3, Day 7, and Day 14
Temperature (°C)
Day 3, Day 7, and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linio Biotech Oy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Nova, Central Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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