In short
A groundbreaking clinical trial is underway to investigate the potential of Allogenic Adipose-Derived Adult Mesenchymal Stem Cells Expanded on Fibrin-Hyaluronic Biological Matrix, also known as Bioengineered Artificial Mesenchymal Sheet (BAMS), in treating venous ulcers of the lower limbs. This innovative approach combines advanced stem cell therapy with a specialized biological matrix, aiming to improve healing outcomes for patients suffering from this challenging condition.
At a glance
- Trial Name
- Clinical Trial with Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
- Trial Phase
- Phase I-II
- Study Design
- Multicenter, Randomized, Controlled, Proof of Concept
- Investigational Product
- Bioengineered Artificial Mesenchymal Sheet (BAMS)
- Target Condition
- Venous ulcer of the lower limbs
- Primary Objective
- Determine feasibility and safety of BAMS
- Key Secondary Objectives
- Assess wound closure time, healing evolution, growth factor concentration, pain reduction, and quality of life
- Key Inclusion Criteria
- Adults with active venous ulcers (5-10 cm²), Grade III on Widmer scale
- Key Exclusion Criteria
- Severe obesity, active neoplasia, systemic infection, immunocompromised status
What is BAMS?
BAMS stands for Bioengineered Artificial Mesenchymal Sheet. It is an advanced therapy medicinal product that uses allogenic adipose-derived adult mesenchymal stem cells grown on a special matrix made of fibrin and hyaluronic acid. In simpler terms, BAMS is a living tissue equivalent that contains stem cells from fat tissue, which are placed on a supportive structure to help treat wounds.
How Does BAMS Work?
BAMS works by applying these specially prepared stem cells directly to the wound. The stem cells, which come from fat tissue, have the ability to promote healing and tissue repair. They are placed on a matrix (a supportive structure) made of fibrin (a protein involved in blood clotting) and hyaluronic acid (a substance that helps retain moisture in the skin). This combination is designed to support the healing process of difficult-to-treat wounds.
What Conditions Does BAMS Treat?
BAMS is being studied for the treatment of venous ulcers of the lower limbs. Venous ulcers are open sores that develop on the legs due to poor blood circulation in the veins. These ulcers can be painful, long-lasting, and difficult to heal with standard treatments.
Clinical Trial Details
A clinical trial is currently being conducted to test the effectiveness and safety of BAMS. Here are some key details about the trial:
- It is a Phase I-II trial, which means it's testing both safety and how well the treatment works.
- The trial is multicenter (conducted at multiple hospitals or clinics) and randomized (participants are randomly assigned to either receive BAMS or a standard treatment).
- The main goals are to determine if BAMS is feasible to use and safe for patients.
Potential Benefits
The researchers are looking at several potential benefits of BAMS, including:
- Faster wound closure compared to standard treatments.
- Improved healing of the ulcer, including changes in depth, size, edges, tissue type, and fluid production.
- Changes in growth factors and other substances in the wound that are important for healing.
- Reduction in pain associated with venous ulcers.
- Improvement in the patient's quality of life.
Who Can Participate?
The trial has specific criteria for who can participate. These include:
- Adults over 18 years old, both men and women.
- People with an active or recurrent venous ulcer on the lower leg, between 5-10 cm² in size.
- The ulcer must be classified as Grade III on the Widmer scale (a way to measure the severity of venous disease).
- Participants must have normal blood flow to their feet, which is checked by feeling for pulses and measuring the ankle-brachial index (a test that compares blood pressure in the ankle to blood pressure in the arm).
Who Cannot Participate?
Some conditions that would prevent someone from participating in the trial include:
- Severe obesity (BMI > 40) or being underweight (BMI < 18.5).
- Active cancer or current cancer treatment.
- Signs of infection in the ulcer.
- Certain other medical conditions like chronic lymphedema, ongoing systemic infections, or uncontrolled heart failure.
- Pregnancy or breastfeeding.
It's important to note that this is a new treatment still being studied. The trial aims to determine if BAMS is safe and effective for treating venous ulcers. If you're interested in participating or learning more, you should discuss this with your healthcare provider.