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Study on Stem Cell Treatment for Venous Ulcers in the Legs Using Bioengineered Artificial Mesenchymal Sheet (BAMS)

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of , a condition where wounds on the legs do not heal properly due to poor blood circulation. The treatment being tested is called , which is made from special cells known as . These cells are grown on a supportive structure called a , which helps them function like living tissue. The purpose of the study is to determine if this treatment is safe and effective for patients with venous ulcers.

Participants in the study will be randomly assigned to receive either the BAMS treatment or a placebo. The study will take place over several months, during which the healing of the ulcers will be closely monitored. Researchers will look at how well the wounds close, how the healing progresses, and any changes in pain levels. They will also assess the overall quality of life for participants after receiving the treatment.

The trial aims to provide valuable information on whether this new approach can improve healing for people with venous ulcers. By understanding the effects of BAMS, researchers hope to offer a new option for those suffering from this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study begins with the signing of the informed consent after reading the patient information sheet. This confirms understanding and agreement to participate in the trial.
Eligibility criteria include being over 18 years old, having an active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm², and having palpable distal pulses in the lower limbs.
Step 2
Treatment administration
The treatment involves the use of a product called Bioengineered Artificial Mesenchymal Sheet (BAMS), which is a living tissue equivalent.
This product contains allogenic adipose-derived adult mesenchymal stem cells expanded on a fibrin-hyaluronic biological matrix.
The product is applied through cutaneous use, meaning it is applied directly to the skin.
Step 3
Monitoring and follow-up
The trial aims to assess the feasibility and safety of the treatment.
Secondary objectives include evaluating the effect on wound closure time, healing evolution, concentration of growth factors related to wound healing, pain evolution, and perceived quality of life after treatment.
Regular follow-up visits will be scheduled to monitor the progress and any side effects.
Step 4
Completion of the trial
The estimated end date for the trial is June 22, 2027.
Upon completion, the data collected will be analyzed to determine the effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

The patient must sign the informed consent after reading the patient information sheet. This means they agree to participate after understanding the study details.
The patient must be over 18 years old. Both men and women can participate.
The patient must have an active or recurring **venous ulcer** on the lower leg. A venous ulcer is a sore that occurs when veins in the leg don't circulate blood properly. The ulcer should be between 5-10 square centimeters in size.
The ulcer must be classified as a Grade III injury on the **Widmer scale**. This scale is used to assess the severity of venous disease.
The patient must have **palpable distal pulses** in the lower limbs. This means the doctor can feel the blood flow in the lower leg and foot.
The **ABI** (Ankle-Brachial Index) must be between 0.8 and 1.3. ABI is a test that compares blood pressure in the ankle with blood pressure in the arm to check for blood flow problems.

Who cannot join the trial?

3 criteria

Patients with a **venous ulcer** of the lower limbs cannot participate. A venous ulcer is a sore on the leg that takes a long time to heal, often due to poor blood flow.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who belong to a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

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Investigated drugs

Allogenic adipose-derived adult mesenchymal stem cells are special cells taken from the fat tissue of donors. These cells have the ability to develop into different types of cells and are used in this trial to help heal venous ulcers on the lower limbs. They are expanded on a fibrin-hyaluronic biological matrix, which provides a supportive environment for the cells to grow and function effectively. The goal is to see if these cells can safely and effectively improve the healing process of the ulcers.

Allogenic Adipose-Derived Adult Mesenchymal Stem Cells Expanded On Fibrin-Hyaluronic Biological Matrix

What is already known about the treatment

Allogenic Adipose-Derived Adult Mesenchymal Stem Cells – This medication is administered through a biological matrix composed of fibrin and hyaluronic acid, applied directly to the site of venous ulcers on the lower limbs. Currently, it is being studied in clinical trials to assess its feasibility and safety for treating these ulcers. The main therapeutic indication is for venous ulcers of the lower limbs, which are chronic wounds that can be difficult to heal. At the molecular level, these stem cells are believed to promote healing by differentiating into various cell types and releasing growth factors that aid tissue repair. This medication falls under the pharmacological classification of regenerative medicine, focusing on using stem cells to repair damaged tissues.

Investigated diseases

Venous ulcer of the lower limbs – This condition occurs when veins in the legs do not efficiently return blood back to the heart, leading to increased pressure in the veins. Over time, this pressure can cause damage to the skin and tissues, resulting in an open sore or ulcer. These ulcers typically develop on the inner side of the leg, just above the ankle. They may start as a small, painful area that gradually enlarges and becomes more painful. The skin around the ulcer can become discolored, swollen, and itchy. If not properly managed, the ulcer can persist for a long time and may become infected.