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Lab-Grown skin could transform burn care for children

NCT ID NCT03229564

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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

0 to 12 years

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: * 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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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

  • Rode Kruis Ziekenhuis

    Beverwijk, 1940, Netherlands

  • Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

    Naples, Italy

  • University Children's Hospital Zurich

    Zurich, 8032, Switzerland

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