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Lab-Grown skin could transform burn healing

NCT ID NCT06745557

Cure Sponsor: CUTISS AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests an engineered skin graft called denovoSkin™, made from a patient's own skin cells, for treating deep burns. It aims to see if this graft can close wounds and reduce scarring better than the standard split-thickness skin graft. The study includes adults and adolescents aged 12 and older with burns covering at least 20% of their body. Each participant receives both treatments on different burn areas to compare outcomes directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
denovoSkin™, an engineered skin graft made from the patient's own skin cells
What this could lead to
If successful, denovoSkin™ could offer a more effective way to close severe burn wounds, potentially reducing scarring and improving recovery for burn patients.
What could go wrong
This is a phase III trial, so while promising, it may not confirm the expected benefits. Risks include graft failure, infection, or scarring that is not better than standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated * Patients of either sex aged ≥12 years * Signed informed consent from the patient and/or legally authorised representative Exclusion Criteria: * Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck) * Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies * Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen \[HbsAg\] or immunoglobulin M total hepatitis B core antibody \[anti-HBc\]), active hepatitis C infection (hepatitis C virus \[HCV\] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion * Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases * Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission * Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine) * Previous treatment with denovoSkin™ * Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and \<30 days for all other IMPs * Patients unwilling or unable to comply with procedures required in this clinical study protocol * Pregnant or lactating women * Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate \<1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting * Patient is the Investigator, one of his/her family members, employees, and other dependent persons

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Conditions

The condition(s) this trial relates to.

burn severe cutaneous adverse reaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Burns

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

    RECRUITING

    Naples, 80131, Italy

  • BG Klinikum Bergmannstrost Halle

    RECRUITING

    Halle, 06112, Germany

  • BG Klinikum Unfallkrankenhaus Berlin

    RECRUITING

    Berlin, 12683, Germany

  • BG-Unfallklinik Murnau

    RECRUITING

    Murnau am Staffelsee, 82418, Germany

  • CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques

    RECRUITING

    Liège, B-4000, Belgium

  • Centre Hospitalier Universitaire de Montpellier

    RECRUITING

    Montpellier, 34295, France

  • Hopital Edouard Herriot Centre des Brûlés de Lyon

    RECRUITING

    Lyon, 69003, France

  • Hospital Universitario La Paz Edificio Traumatología

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitatrio y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Maasstad Hospital Dep. Burn Wound Centre

    RECRUITING

    Rotterdam, 3079 DZ, Netherlands

  • Medizinische Hochschule Hannover

    NOT_YET_RECRUITING

    Hanover, 30625, Germany

  • Pharmacie Hôpital Conception

    RECRUITING

    Marseille, 13005, France

  • Rode Kruis Ziekenhuis

    RECRUITING

    Beverwijk, 1942, Netherlands

  • Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej

    RECRUITING

    Łęczna, 21-010, Poland

  • Santobono-Pausilipon

    RECRUITING

    Naples, 80129, Italy

  • Unidade de Queimados do CHUC

    RECRUITING

    Coimbra, 3000-075, Portugal

  • Universtitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

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