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Autologous Skin-Derived Adult Fibroblasts Expanded

A groundbreaking clinical trial is underway to evaluate the safety and efficacy of a new tissue-engineered autologous skin substitute for reconstructive surgery in patients with basal cell carcinoma. This phase II study aims to explore the potential of nanostructured artificial skin, created using the patient’s own cells, as an alternative to traditional autografts in Mohs surgery. The trial focuses on assessing the safety, feasibility, and effectiveness of this innovative approach in improving patient outcomes and quality of life.

Table of Contents

What is Autologous Skin-Derived Adult Fibroblasts Expanded?

Autologous Skin-Derived Adult Fibroblasts Expanded is an advanced medical treatment that uses a patient’s own skin cells to create a personalized skin substitute. This innovative therapy is being studied for use in reconstructive surgery following the removal of basal cell carcinoma, a common type of skin cancer[1].

The treatment is also known by several other names, including:

  • PHIT
  • PHITAH
  • Autologous skin differentiated adult keratinocytes and fibroblasts cell-sheet

How Does It Work?

The process involves taking a small sample of the patient’s healthy skin and extracting two types of cells:

  1. Keratinocytes: These are the main cells found in the outer layer of the skin (epidermis).
  2. Fibroblasts: These cells are found in the deeper layer of the skin (dermis) and produce collagen, which gives skin its strength and elasticity.

These cells are then grown and expanded in a laboratory. They are combined with either agarose (a gel-like substance) or hyaluronic acid (a naturally occurring substance in the skin) to create a living tissue equivalent. This engineered skin substitute is then implanted into the patient during reconstructive surgery[1].

Medical Conditions Treated

The primary medical condition being studied for this treatment is reconstructive skin surgery in basal cell cancer, specifically following Mohs surgery. Mohs surgery is a precise surgical technique used to treat skin cancer[1].

Current Clinical Trial

A Phase II clinical trial is currently underway to evaluate the safety and efficacy of this autologous skin substitute for reconstructive surgery in patients with basal cell carcinoma. The trial aims to confirm that the treatment is safe and feasible for use in surgical implantation[1].

Who is Eligible for the Treatment?

The clinical trial has specific eligibility criteria. Patients may be eligible if they:

  • Are 18 years of age or older
  • Have a clinical and dermatoscopic diagnosis of basal cell carcinoma on the scalp, torso, or extremities
  • Have lesions that cannot be closed by direct suture or flaps
  • Are indicated for Mohs surgery

However, patients may not be eligible if they have certain conditions, such as locally advanced basal cell carcinoma, other pathologies that could interfere with healing, or known allergies to certain antibiotics[1].

Safety and Efficacy

The main objectives of the current clinical trial are to assess:

  • Safety: Monitoring for adverse events and reactions related to the treatment
  • Feasibility: Evaluating how well the engineered skin attaches to the recipient tissue and facilitates wound healing
  • Efficacy: Measuring the percentage of epithelialization (skin regrowth) 21 days after surgery

The trial will also compare this new treatment to traditional autografts (skin grafts from the patient’s own body) in terms of safety, efficacy, and aesthetic outcomes[1].

Potential Advantages

While the full benefits are still being studied, this treatment may offer several potential advantages:

  • Use of the patient’s own cells, potentially reducing the risk of rejection
  • Possibly better aesthetic outcomes compared to traditional skin grafts
  • Potential for improved healing and reduced scarring
  • May eliminate the need for a separate donor site, as required in traditional skin grafts

It’s important to note that these potential advantages are still being evaluated in clinical trials, and more research is needed to confirm the long-term benefits and safety of this treatment[1].

Aspect Details
Study Type Phase II clinical trial
Main Objective Evaluate safety and feasibility of nanostructured autologous artificial skin
Target Condition Basal cell carcinoma requiring reconstructive surgery (Mohs surgery)
Investigational Product Autologous skin-derived adult keratinocytes and fibroblasts expanded in fibrin-based matrix
Key Endpoints Safety, feasibility, efficacy (epithelialization), pain levels, aesthetic outcomes, quality of life
Inclusion Criteria Adults with basal cell carcinoma on scalp, torso, or extremities requiring Mohs surgery
Exclusion Criteria Locally advanced cancer, face lesions, pregnant/breastfeeding women, coagulation disorders
Comparative Aspects Efficacy, safety, and economic efficiency compared to traditional autografts

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to confirm the safety and feasibility of using nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid for reconstructive surgery in patients with basal cell carcinoma who have undergone Mohs surgery.
  • Who can participate in this clinical trial? Adults (18 years or older) of any sex and racial origin with a clinical and dermatoscopic diagnosis of basal cell carcinoma on the scalp, torso, or extremities that requires Mohs surgery can participate. Participants must provide informed consent and meet specific inclusion criteria.
  • What is the investigational product being tested? The investigational product is a living tissue equivalent made of autologous skin-derived adult keratinocytes and fibroblasts expanded in either a fibrin-agarose or fibrin-hyaluronic acid biological matrix. This creates a personalized skin substitute for each patient.
  • How will the effectiveness of the treatment be measured? The effectiveness will be measured through various factors, including the percentage of epithelialization 21 days after surgery, time until complete healing, pain levels, aesthetic appearance of the lesion, and impact on quality of life. Additionally, structural and functional properties of the skin will be analyzed using techniques such as ultrasound and skin biopsies.
  • What are the potential benefits of this new treatment compared to traditional methods? The potential benefits include improved healing, reduced pain (especially due to the absence of a donor site), better aesthetic outcomes, and enhanced quality of life for patients. The trial also aims to compare the economic efficiency of this new treatment with traditional autografts.

Ongoing Clinical Trials on Autologous Skin-Derived Adult Fibroblasts Expanded

  • Study on Autologous Skin-Derived Keratinocytes and Fibroblasts for Patients with Basal Cell Carcinoma Undergoing Reconstructive Surgery

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Autologous: Derived from the same individual. In this context, it refers to using a patient's own cells to create the skin substitute.
  • Basal Cell Carcinoma: A type of skin cancer that begins in the basal cells, which produce new skin cells as old ones die off.
  • Mohs Surgery: A precise surgical technique used to treat skin cancer by progressively removing thin layers of cancer-containing skin until only cancer-free tissue remains.
  • Epithelialization: The process by which epithelial cells (which make up the outer layer of skin) grow and cover a wound surface, an important part of wound healing.
  • Nanostructured: Having a structure manipulated on an extremely small scale, typically between 1 to 100 nanometers.
  • Fibrin Matrix: A network of fibrin proteins that forms a scaffold for cell growth and tissue repair.
  • Keratinocytes: The predominant cell type in the epidermis, the outermost layer of skin, responsible for forming a barrier against environmental damage.
  • Fibroblasts: Cells that produce collagen and other fibers, playing a crucial role in wound healing and maintaining skin structure.
  • Autograft: A tissue graft taken from one part of a person's body and transplanted to a different site on the same person.
  • Transepidermal Water Loss: The amount of water that passively evaporates through skin, used as a marker of skin barrier function.

References

  1. http://clinicaltrials.eu/trial/study-on-autologous-skin-derived-keratinocytes-and-fibroblasts-for-patients-with-basal-cell-carcinoma-undergoing-reconstructive-surgery/