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Can Lab-Grown skin permanently replace severe burn wounds?

NCT ID NCT02350205

Cure Sponsor: CHU de Quebec-Universite Laval 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests a lab-grown skin substitute made from a patient's own cells as a permanent replacement for severe burn wounds. It is for people with deep burns covering over half their body, where donor skin is scarce. The study compares how well this substitute grafts and heals compared to standard skin grafts, and evaluates scarring and safety.

What this could mean

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

Active substance
Self-assembled skin substitute (SASS), a lab-grown skin graft made from the patient's own cells
What this could lead to
If successful, this could provide a permanent skin replacement for people with massive burns, reducing the need for repeated grafting and improving recovery.
What could go wrong
This is an early-stage trial, so the skin substitute may not take as well as hoped or could cause complications. Results from a small group may not apply to all burn patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 52 people

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

Started

Dec 2015

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon; * Limited availability of donor sites for autografts; * Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors. Exclusion Criteria: * Skin grafting needed only on the face, hands, feet, ears or genital area; * Connective tissue diseases; * Hypersensitivity to bovine proteins; * Coagulation disorders prior being burned; * Immunodeficiency prior being burned; * Uncontrolled diabetes prior being burned; * Permanent wound coverage before SASS grafts are ready;

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Conditions

The condition(s) this trial relates to.

burn

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 places running it

    8 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • BC Children's Hospital Plastic Surgery Clinic

    RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • CHU de Québec - Unité des grands brûlés

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Foothill Medcial Centre

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • Hospital for Sick Children (Sickkids)

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Hôpital Sainte Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Mackenzie Health Science's Centre

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1N1, Canada

  • Winnipeg Health Science Center

    RECRUITING

    Winnipeg, Manitoba, R3A 1R9, Canada

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