Lab-Grown skin could transform burn care for children
NCT ID NCT03229564
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing a lab-grown skin substitute called denovoSkin in children with deep burns. The engineered skin is made from the child's own cells and is compared to the standard treatment of using a split-thickness skin graft. The goal is to see if denovoSkin can cover burns more effectively and safely, potentially reducing the amount of healthy skin needed for grafting. The study involves 12 children under 12 years old who have deep partial or full-thickness burns requiring surgical coverage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an autologous bio-engineered dermo-epidermal skin substitute called denovoSkin (EHSG-KF)
- What this could lead to
- If successful, this could offer a more effective and safer way to cover deep burns in children, potentially reducing the need for multiple surgeries and improving healing outcomes.
- What could go wrong
- This is an early-stage trial with only 12 children, so results may not apply broadly. The engineered skin might not integrate as well as standard grafts, and there is a risk of infection or rejection.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2017
- Expected to finish
-
Jun 2028
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
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0 to 12 years
- Sex
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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 Hide 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: * Age: \<12 years of age * Deep partial thickness and/or full-thickness burns requiring surgical wound coverage * Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion. * Signed Informed consent Exclusion Criteria: * Patients tested positive for HBV, HCV, syphilis or HIV * Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing) * Severe drug and alcohol abuse * Patients with a known history of malignancy * Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion * Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen * Previous enrolment of the patient into the current phase II study * Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study * Patients or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) * Pregnant or breast feeding females * Suspicion of child abuse * Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands) * Enrolment of the Investigator, his/her family members, employees and other dependent persons
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dipartimento di Chirurgia Pediatrica Ospedale dei bambini Vittorio Buzzi
Milan, Italy
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Rode Kruis Ziekenhuis
Beverwijk, 1940, Netherlands
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Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Naples, Italy
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University Children's Hospital Zurich
Zurich, 8032, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can video games and pilates rebuild strength after severe burns?
- DNA sequencing could reveal hidden bacteria in burn wounds
- Can a dissolvable dressing get burn patients to skin grafts faster?
- Could a special dressing make skin grafts unnecessary for burns?
- Can tiny skin grafts heal wounds without leaving a second scar?
- Lab-Grown skin could transform burn healing