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Phase 2a Study Comparing Autologous Epidermal Cell Suspension (Epi-001) to Standard Meek Micrograft in Patients with Deep Dermal and Full‑Thickness Burn Wounds

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves individuals with deep dermal and full-thickness burn wounds. The experimental product, identified as Epi-001, is an autologous epidermal cell suspension that is placed directly on the wound surface. It is being compared with the usual treatment of a meshed Meek micrograft, which is a type of skin graft that is spread out to cover a larger area.

The purpose of the trial is to compare how quickly each treatment leads to epithelialization, the process by which new skin grows over the wound. In this Phase 2a study, each participant receives both treatments on separate halves of the same wound, and the assignment is hidden from the evaluators. Wound healing is checked on days 10, 14 and 21 after the procedure, and scar quality is later assessed using standard tools, while any additional surgeries or complications are recorded.

The investigational product is classified as an ATMP, a specially prepared medical therapy. Participants are followed for up to one year to monitor long‑term healing, scar appearance, and any safety concerns related to the treatments.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment Confirmation

    You sign the consent form that explains the study, confirming that you agree to take part.

    Your health information is reviewed to ensure you meet the study requirements.

  2. Step 2

    Baseline Evaluation

    A medical team measures the size and depth of your burn wounds and takes photographs for reference.

    Your overall health status is recorded, including any medications you are currently using.

  3. Step 3

    Surgical Preparation and Tissue Collection

    You undergo surgery to remove the damaged burn tissue.

    A small piece of healthy skin is taken from another area of your body to create the study medication.

  4. Step 4

    Preparation of Autologous Epidermal Cell Suspension

    The skin sample you provided is processed in a laboratory to create a liquid containing your own skin cells, called Epi-001.

    The final product is a 4 ml suspension that will be applied directly to the wound.

  5. Step 5

    Randomized Application of Treatments

    Your wound is divided into two equal halves.

    One half receives the 4 ml topical application of Epi-001.

    The other half receives the standard care method known as a Meek micrograft, which uses small pieces of your own skin to cover the wound.

  6. Step 6

    Dressing and Immediate Post‑operative Care

    Both halves of the wound are covered with sterile dressings.

    You remain in the hospital for observation and receive pain management as needed.

  7. Step 7

    Follow‑up Visits for Healing Assessment

    You return for clinic visits on postoperative days 10, 14, and 21.

    During each visit, the medical team checks how much of the wound surface has become new skin (epithelialization) and records whether at least 95 % of each half has healed.

  8. Step 8

    Secondary Procedures if Needed

    If either half of the wound has not healed sufficiently, a secondary procedure (re‑operation) may be performed to improve healing.

    The number of any such procedures is recorded as part of the study.

  9. Step 9

    Long‑term Scar Assessments

    At 3, 6, and 12 months after surgery, you attend appointments to evaluate the appearance and flexibility of the scar.

    Scar quality is measured using the Patient and Observer Scar Assessment Scale (POSAS) and a device called the Cutometer MPA580, which tests skin elasticity.

  10. Step 10

    Study Completion

    All final measurements are recorded, and you receive a summary of your participation.

    No further study‑related visits are required unless medically necessary.

Who can join the trial?

6 criteria

  • Be a man or woman between 18 and 65 years old.
  • Provide written permission (signed consent) to join the study.
  • Have a total burn covering less than 30 % of the body surface area (TBSA), which means the burned skin is less than 30 % of your whole body.
  • Have a deep dermal or full‑thickness burn (a severe burn that reaches the deep layers of skin) that needs surgical removal (excision) and a skin graft, with a suitable wound area on the trunk or a limb (away from a major joint) that can be split into two side‑by‑side zones about 15‑20 cm² each.
  • If you are a woman who could become pregnant, you must use an effective birth‑control method during the study and have a negative pregnancy test at the start.
  • The burn must be caused by heat (thermal) or chemicals.

Who cannot join the trial?

8 criteria

  • Having any other disease or treatment that the doctor believes could change how the study works.
  • Being infected with HIV (a virus that attacks the immune system), hepatitis C (HCV) or hepatitis B (HBV) (viruses that affect the liver), HTLV (a virus that can affect the immune system), or syphilis (a sexually transmitted infection).
  • Having the burn on the face, scalp, perineum (the area between the genitals and the anus), hands, or feet, or having a risk that the whole limb could lose blood flow (circumferential limb ischemia).
  • Having a wound that is heavily dirty or infected (grossly contaminated/infected) at the time the study treatment is applied.
  • Being unable to understand the study because of mental limitations, unwillingness, or language problems.
  • Being pregnant or breastfeeding.
  • Being allergic to any ingredients in the study products, including fibrin sealants (a glue used to help close wounds) or the dressings used on the wound.
  • Already taking part in another clinical trial that could interfere with this one (conflicting interventional trial).
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Investigated drugs

  • Epi-001

    is a specially prepared suspension of a patient’s own skin cells that is applied directly onto a deep or full‑thickness burn wound. The cells are taken from a small piece of the patient’s skin, grown in the laboratory, and then mixed into a liquid that can be spread over the wound. In the trial, this cell suspension is being tested to see if it helps the wound heal faster by forming new skin more quickly.

  • Meek micrograft

    is a technique that uses tiny pieces of the patient’s own skin, cut into a grid‑like pattern, and then stretched (meshed) to cover a larger area of the burn wound. The micrografts are placed on the wound to act as a natural “seed” for new skin growth. In the study, this standard method is used as the comparison to see whether the new cell suspension (Epi‑001) can improve healing.

What is already known about the treatment

Epi-001 - Epi-001 is a cell suspension applied directly to the wound, using about 4 ml of the liquid placed on the burn surface. It is an investigational autologous cell‑based therapy (an ATMP) that is still being studied in clinical trials and not yet approved for routine use. The product is meant to treat deep dermal and full‑thickness burn wounds by helping the skin heal faster. It works by delivering the patient’s own epidermal cells, which attach to the wound, multiply and form a new skin layer.

Investigated diseases

Deep partial‑thickness and full‑thickness burns - These are severe skin injuries that extend through the epidermis into the deeper layers of the dermis. A deep partial‑thickness burn destroys most of the dermis and often causes intense pain, while a full‑thickness burn removes the entire dermis and can be painless because nerve endings are lost. Both types initially appear as red or white, leathery areas that may blister or slough. Over time the wound surface gradually closes as new skin cells grow, but full‑thickness burns heal more slowly and can result in thicker scar tissue and tightening of the skin.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527004-25-00Estimated enrolment25 patientsSponsorRegion Oestergoetland

sourced from the EU Clinical Trials Register and site verification

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