In short
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.
At a glance
- 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
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. This innovative therapy, also known as PHIT or PHITAH, is being developed to help patients undergoing reconstructive surgery for basal cell carcinoma.
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.
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. 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:
- A small sample of the patient's healthy skin is taken.
- The skin sample is processed to isolate keratinocytes and fibroblasts.
- These cells are grown and expanded in a laboratory.
- The expanded cells are combined with a special matrix (either fibrin-agarose or fibrin-hyaluronic acid) to create a living tissue equivalent.
- This tissue equivalent is then implanted during the reconstructive surgery to help repair the area where the skin cancer was removed.
Current Clinical Trial
A Phase II clinical trial is currently underway to evaluate the safety and efficacy of this treatment. 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.
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)
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
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)
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
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
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.