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Bilayer Engineered Collagen Hydrogel-Based Skin Graft Composed Of Autologous Keratinocytes And Fibroblasts

Clinical trials are underway to evaluate the safety and effectiveness of a new skin graft treatment called EHSG-KF (also known as denovoSkin™). This innovative therapy uses a bilayer engineered collagen hydrogel-based skin graft composed of a patient’s own (autologous) keratinocytes and fibroblasts. The trials aim to compare EHSG-KF to standard split-thickness skin grafts (STSG) for treating deep partial and full-thickness burns, as well as other full-thickness skin defects in both adults and children.

Table of Contents

What is EHSG-KF?

EHSG-KF stands for “engineered hydrogel skin graft – keratinocytes and fibroblasts”. It is a new type of skin graft being developed to treat severe burns and other skin defects[1]. This advanced therapy uses the patient’s own skin cells to create a personalized skin graft.

Specifically, EHSG-KF is a bilayer engineered collagen hydrogel-based skin graft that contains two types of cells from the patient’s skin:

  • Keratinocytes: These are the main cells found in the outer layer of skin (epidermis). They form a protective barrier.
  • Fibroblasts: These cells are found in the deeper layer of skin (dermis). They help produce collagen and other proteins that give skin its strength and elasticity.

The cells are combined with a special collagen gel to create a living, personalized skin graft[2].

How Does It Work?

The process of creating and using EHSG-KF involves several steps:

  1. A small skin biopsy is taken from the patient.
  2. The keratinocytes and fibroblasts are isolated from this biopsy and grown in a laboratory.
  3. These cells are then combined with a collagen hydrogel to create the skin graft.
  4. The engineered skin graft is then applied to the patient’s wound or burn area.
  5. Over time, the graft should integrate with the surrounding skin and help heal the wound.

This approach aims to provide a more effective and natural healing process compared to traditional skin grafts[3].

What Conditions Does It Treat?

EHSG-KF is being developed to treat several types of skin injuries and defects, including:

  • Deep partial and full-thickness burns: These are severe burns that damage multiple layers of skin[1].
  • Full-thickness skin defects: These can result from various causes such as trauma, surgery, or certain skin conditions[4].
  • Scar reconstruction: It may help improve the appearance and function of scarred skin.
  • Removal of large skin lesions: Such as certain types of moles or tumors that require significant skin removal.

The treatment is being studied in both adults and children, showing its potential to help a wide range of patients[3].

Benefits

EHSG-KF offers several potential advantages over traditional skin grafts:

  • Personalized treatment: Since it uses the patient’s own cells, there’s less risk of rejection.
  • Improved healing: The living cells in the graft may promote better wound healing and skin regeneration.
  • Better cosmetic results: It aims to provide a more natural-looking outcome with less scarring.
  • Reduced donor site impact: Only a small biopsy is needed, potentially reducing pain and complications at the donor site compared to larger skin grafts.
  • Treatment for large areas: It may allow treatment of larger wound areas than traditional grafts.

Clinical Trials

EHSG-KF is currently being studied in several clinical trials to evaluate its safety and effectiveness[1]. These include:

  • A Phase III trial in adults and adolescents with deep partial and full-thickness burns.
  • A Phase IIb trial in adults and adolescents with partial deep dermal and full-thickness burns.
  • A Phase IIb trial in children with partial deep dermal and full-thickness burns.
  • A Phase II trial in adults and children with full-thickness skin defects.

These trials are comparing EHSG-KF to standard split-thickness skin grafts (STSG) to see if it provides better outcomes[2].

Safety and Side Effects

As EHSG-KF is still in clinical trials, its full safety profile is not yet known. However, some potential risks and side effects being monitored include:

  • Infection: As with any wound treatment, there’s a risk of infection.
  • Graft failure: The graft may not take or integrate properly in some cases.
  • Scarring: While aiming to reduce scarring, some scarring may still occur.
  • Allergic reactions: Some patients may be allergic to components used in the graft preparation.

The clinical trials are carefully monitoring patients for any adverse events to ensure the treatment’s safety[3].

Future Outlook

EHSG-KF represents an exciting advancement in regenerative medicine and burn treatment. If the clinical trials show positive results, it could become a valuable new option for treating severe burns and skin defects.

Future research may explore using this technology for other skin conditions or combining it with other advanced therapies. However, it’s important to note that EHSG-KF is still experimental, and more research is needed to fully understand its long-term effects and optimal use[4].

Aspect Details
Treatment EHSG-KF (denovoSkin™): Bilayer engineered collagen hydrogel-based skin graft
Composition Autologous keratinocytes and fibroblasts
Target Conditions Deep partial and full-thickness burns, full-thickness skin defects
Patient Groups Adults, adolescents, and children (age varies by study)
Comparison Standard split-thickness skin grafts (STSG)
Primary Endpoints Wound closure, scar quality, ratio of covered surface area to donor site
Secondary Endpoints Infection rates, graft take, epithelialization, quality of life assessments
Follow-up Duration Up to 3 years post-grafting
Key Assessments POSAS questionnaire, Cutometer®, DSM ColorMeter®, optional biopsies

FAQ

  • What is EHSG-KF and how does it work? EHSG-KF is a bilayer engineered collagen hydrogel-based skin graft made from a patient's own skin cells (keratinocytes and fibroblasts). It's designed to provide a more effective and potentially less scarring alternative to traditional skin grafts for treating severe burns and other skin defects.
  • Who can participate in these clinical trials? The trials include patients with deep partial and full-thickness burns, as well as those with full-thickness skin defects from various causes. Age requirements vary by study, with some trials including patients as young as 1 year old and others focusing on those 12 years and older.
  • What are the main goals of these clinical trials? The primary objectives are to evaluate the efficacy and safety of EHSG-KF compared to standard split-thickness skin grafts. This includes assessing wound closure, scar quality, graft take, and epithelialization (skin regrowth).
  • How long do the trials last? While the initial treatment and assessment periods last several months, some trials include follow-up evaluations for up to 3 years to assess long-term outcomes such as scar quality and skin growth.
  • What are some potential benefits of EHSG-KF over traditional skin grafts? Potential benefits being studied include better scar quality, improved wound closure, reduced donor site requirements (as EHSG-KF can cover a larger area from a smaller skin sample), and possibly better functional and cosmetic outcomes for patients with severe burns or skin defects.

Ongoing Clinical Trials on Bilayer Engineered Collagen Hydrogel-Based Skin Graft Composed Of Autologous Keratinocytes And Fibroblasts

  • Study on the Effectiveness of EHSG-KF Skin Graft for Patients with Deep Partial and Full-Thickness Burns

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Poland +2

  • Study on the Safety and Effectiveness of EHSG-KF for Treating Deep Dermal and Full Thickness Burns in Children

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy The Netherlands

  • Study on the Safety and Effectiveness of EHSG-KF for Treating Full-Thickness Skin Defects in Adults and Children

    Not recruiting

    2 1 1
    Investigated drugs:
    Italy The Netherlands

  • Study on EHSG-KF for Treating Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Autologous: Using cells or tissues obtained from the same individual. In this case, the skin graft is made using the patient's own skin cells.
  • Bilayer: Having two layers. The engineered skin graft has two layers to mimic natural skin structure.
  • Collagen: A protein that provides structure and support in skin and other tissues.
  • Cutometer®: A device used to measure skin elasticity and other properties.
  • DSM ColorMeter®: A tool used to measure skin color, often used to assess scar appearance.
  • Epithelialization: The process of skin cells growing to cover a wound.
  • Fibroblasts: Cells that produce collagen and other components of connective tissue in the skin.
  • Full-thickness burns: Burns that destroy all layers of the skin and may affect underlying tissues.
  • Hydrogel: A gel-like material containing water, used as a base for the engineered skin graft.
  • Keratinocytes: The main type of cells found in the outer layer of the skin.
  • POSAS: Patient and Observer Scar Assessment Scale, a tool used to evaluate scar appearance and qualities.
  • Split-thickness skin graft (STSG): A traditional type of skin graft that uses only the top layers of skin from a donor site on the patient's body.
  • TBSA: Total Body Surface Area, used to describe the extent of burns on a patient's body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-ehsg-kf-skin-graft-for-patients-with-deep-partial-and-full-thickness-burns/
  2. http://clinicaltrials.eu/trial/study-on-ehsg-kf-for-treating-partial-deep-dermal-and-full-thickness-burns-in-adults-and-adolescents/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-ehsg-kf-for-treating-deep-dermal-and-full-thickness-burns-in-children/
  4. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-ehsg-kf-for-treating-full-thickness-skin-defects-in-adults-and-children/