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Autologous Skin-Derived Adult Keratinocytes Expanded

This article discusses a Phase II clinical trial investigating the use of autologous skin-derived adult keratinocytes and fibroblasts for reconstructive surgery in patients with basal cell carcinoma. The study aims to evaluate the safety, feasibility, and efficacy of nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid. This innovative approach could potentially improve outcomes for patients undergoing Mohs surgery for basal cell carcinoma.

Table of Contents

What is Autologous Skin-Derived Adult Keratinocytes Expanded?

Autologous Skin-Derived Adult Keratinocytes Expanded is an advanced medical treatment that uses a patient’s own skin cells to create a living tissue equivalent[1]. This innovative therapy, also known as PHIT or PHITAH, is being developed to help patients undergoing reconstructive surgery for basal cell carcinoma[1].

The treatment involves two main components:

  • Autologous skin-derived adult keratinocytes: These are the main cells that make up the outer layer of your skin (epidermis).
  • Autologous skin-derived adult fibroblasts: These cells are found in the deeper layer of your skin (dermis) and help in producing collagen and other important skin components.

These cells are expanded (grown in larger numbers) in a laboratory and combined with either a fibrin-agarose or fibrin-hyaluronic acid biological matrix to create a living tissue equivalent[1].

Medical Condition Treated

This treatment is being developed specifically for patients undergoing reconstructive skin surgery for basal cell carcinoma, particularly those who have had Mohs surgery[1]. Basal cell carcinoma is a type of skin cancer that begins in the basal cells of the outer layer of skin. Mohs surgery is a precise surgical technique used to treat skin cancer, where thin layers of cancer-containing skin are progressively removed and examined until only cancer-free tissue remains.

How Does It Work?

The treatment works by creating a personalized skin substitute using the patient’s own cells. Here’s a simplified explanation of the process:

  1. A small sample of the patient’s healthy skin is taken.
  2. The skin sample is processed to isolate keratinocytes and fibroblasts.
  3. These cells are grown and expanded in a laboratory.
  4. The expanded cells are combined with a special matrix (either fibrin-agarose or fibrin-hyaluronic acid) to create a living tissue equivalent.
  5. This tissue equivalent is then implanted during the reconstructive surgery to help repair the area where the skin cancer was removed[1].

Current Clinical Trial

A Phase II clinical trial is currently underway to evaluate the safety and efficacy of this treatment[1]. The trial, known as “NanoGSkin/CB/2019,” aims to:

  • Confirm the safety of the treatment by monitoring adverse events.
  • Verify the feasibility of surgical implantation.
  • Compare its effectiveness to traditional autografts (skin grafts taken from another part of the patient’s body).
  • Analyze the histological and functional properties of the implanted tissue.
  • Study the impact on skin homeostasis and aesthetic outcomes.
  • Evaluate the economic aspects of the treatment compared to standard approaches[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
  • Require Mohs surgery
  • Are willing to use effective contraception (if applicable)[1]

However, patients may not be eligible if they have:

  • Locally advanced basal cell carcinoma with deep tissue infiltration
  • Lesions on the face (except for frontal-lateral area and the temple)
  • Injuries requiring urgent surgical intervention
  • Known allergies to certain antibiotics used in the manufacturing process
  • Coagulation disorders that may interfere with healing[1]

Safety and Efficacy

The primary focus of the current clinical trial is to assess the safety and feasibility of this treatment. Researchers are monitoring:

  • Adverse events and reactions
  • Complications in wound healing
  • The ability of the tissue to adhere to the recipient site
  • The integrity of the implanted tissue
  • The rate of re-epithelialization (regrowth of the outer layer of skin)[1]

Efficacy is being evaluated through various measures, including:

  • Percentage of epithelialization after 3 weeks
  • Time until complete healing
  • Pain levels
  • Aesthetic appearance of the treated area
  • Impact on quality of life[1]

Potential Benefits

While the treatment is still in the clinical trial phase, it has the potential to offer several benefits:

  • Personalized treatment using the patient’s own cells, potentially reducing the risk of rejection
  • Possible improvement in wound healing and aesthetic outcomes compared to traditional skin grafts
  • Potential reduction in pain and complications associated with donor site wounds (as no separate donor site is needed)
  • Possible improvement in overall quality of life for patients undergoing reconstructive surgery[1]

It’s important to note that as this treatment is still under investigation, its full benefits and potential risks are yet to be fully understood. Patients interested in this treatment should discuss it with their healthcare provider and consider participation in clinical trials if appropriate.

Aspect Details
Study Type Phase II clinical trial
Main Objective Evaluate safety and feasibility of nanostructured autologous artificial skin for reconstructive surgery in basal cell carcinoma patients
Investigational Product Autologous skin-derived adult keratinocytes and fibroblasts expanded in fibrin matrix with agarose or hyaluronic acid
Target Population Adults with basal cell carcinoma requiring Mohs surgery
Primary Endpoints Safety (adverse events), Feasibility (surgical suturability, adherence to recipient tissue)
Secondary Endpoints Efficacy (epithelialization, pain, aesthetic appearance), Structural characteristics, Economic evaluation
Follow-up Period Up to 1 year

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate 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? Participants must be 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. The lesions must be of a certain size that doesn't allow for surgical closure by direct suture or flaps, and there must be an indication for Mohs surgery.
  • What are the main components of the investigational product? The investigational product consists of autologous skin-derived adult keratinocytes and fibroblasts expanded in a fibrin matrix combined with either agarose or hyaluronic acid. These components are used to create a living tissue equivalent for reconstructive surgery.
  • 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, the degree of pain experienced, the aesthetic appearance of the lesion, quality of life indices, and structural characteristics of the skin using techniques such as doppler ultrasound and histological tests.
  • Are there any specific exclusion criteria for this trial? Yes, some exclusion criteria include locally advanced basal cell carcinoma with deep tissue infiltration, lesions on the face (except for frontal-lateral area and temple), injuries requiring urgent surgical intervention, infected or necrotic injuries, and known allergies to antibiotics that could be part of the impurities in the manufacturing process (gentamicin and amphotericin B).

Ongoing Clinical Trials on Autologous Skin-Derived Adult Keratinocytes 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 skin cells taken from the patient's own body.
  • Keratinocytes: The predominant cell type in the outer layer of the skin (epidermis) that produces keratin, a protein that helps form a protective barrier.
  • Fibroblasts: Cells found in connective tissue that produce collagen and other fibers, playing a crucial role in wound healing and tissue repair.
  • Basal Cell Carcinoma: A type of skin cancer that begins in the basal cells, which are responsible for producing 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 and examining them until only cancer-free tissue remains.
  • Nanostructured: Having a structure manipulated on an extremely small scale, typically at the molecular level.
  • Fibrin Matrix: A network of fibrin proteins that forms a scaffold for cell growth and tissue regeneration.
  • Agarose: A polysaccharide polymer material derived from seaweed, used in this context as a component of the artificial skin matrix.
  • Hyaluronic Acid: A naturally occurring substance in the body that helps retain moisture and provides cushioning for tissues.
  • Epithelialization: The process by which epithelial cells (such as those in the skin) spread and cover a wound surface, an important part of wound healing.
  • Transepidermal Water Loss: The amount of water that passively evaporates through the skin, used as a measure of the skin's 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/