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Study on BGC101 for Treating Peripheral Arterial Disease with Critical Limb Ischemia in Patients Not Responding to Standard Treatments

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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 a condition known as peripheral arterial disease (PAD), specifically in patients with a severe form called critical limb ischemia (CLI). This condition affects blood flow to the limbs, often leading to pain and potential limb loss. The study is testing a new treatment called BGC101, which is a type of cell therapy. This treatment involves using special cells derived from the patient's own blood, including endothelial progenitor cells, haematopoietic stem/progenitor cells, activated dendritic cells, and T helper cells. These cells are prepared as a suspension for injection and are administered through an intramuscular injection.

The purpose of the study is to evaluate how feasible, safe, and effective BGC101 is for patients with PAD and CLI who have not responded to standard treatments and do not have the option for further surgical procedures to restore blood flow. The study will be conducted in two phases, with some participants receiving the actual treatment and others receiving a placebo. Participants will be monitored for any side effects and the overall health of their limbs over the course of the study.

Throughout the study, researchers will assess the safety of BGC101 by observing any adverse events, changes in vital signs, and reactions at the injection site. They will also evaluate the treatment's effectiveness by measuring the rate of major amputations and the survival of limbs without amputation over a 12-month period. This study aims to provide new insights into treating PAD with CLI, offering hope for patients who have limited treatment options.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will undergo a physical examination and provide a detailed medical history. This is to ensure you meet the study's eligibility criteria.
You will be informed about the study's purpose, procedures, and potential risks. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.
Step 2
Treatment administration
The treatment involves the use of BGC101, which consists of special cells derived from your own blood. These cells include endothelial progenitor cells, haematopoietic stem/progenitor cells, activated dendritic cells, and t helper cells.
The treatment is administered as an intramuscular injection. The exact dosage and frequency will be determined by the study protocol and communicated to you by the study team.
Step 3
Follow-up visits
You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and assessments of your vital signs.
The study team will also monitor for any side effects or adverse reactions to the treatment. It is important to report any new symptoms or concerns during these visits.
Step 4
End of study evaluation
At the end of the study period, you will undergo a final evaluation. This will include a comprehensive assessment of your health and the overall effectiveness of the treatment.
The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

12 criteria

Male or female patient who can complete the study and follow instructions.
Capable of understanding the purpose of the study and the contents of the informed consent form.
Aged at least 18 years.
Non-pregnant and non-lactating female patients.
Have the clinical indications diagnostic of Chronic Limb Ischemia (CLI) based on Rutherford category 4-5. (This refers to a classification system used to describe the severity of peripheral arterial disease.)
Have at least one of the hemodynamic indicators of severe peripheral arterial occlusive disease:
- WIfI ischemia grade ≥2 (This is a grading system used to assess the severity of ischemia, which is a lack of blood flow.)
- Toe pressure <40 mmHg (A measure of blood pressure in the toes.)
- Ankle pressure <70 mmHg (A measure of blood pressure in the ankles.)
- TcPO2 < 40mmHg (A measure of the oxygen level in the skin.)
- Meeting one of the following conditions:
  - Poor candidate for standard revascularization treatment for peripheral arterial disease due to unfavorable anatomy or high surgical/intervention risk based on the patient’s underlying health conditions.
  - After undergoing clinically ineffective revascularization.
  - Four weeks or more after a revascularization failure.

Who cannot join the trial?

3 criteria

Patients who have responded to standard treatments or risk factor control for their condition.
Patients who have the option for further revascularization treatment. Revascularization is a procedure to restore blood flow to the affected area.
Patients who do not have peripheral arterial disease (PAD) or chronic-limb threatening ischemia (CLTI).

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Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

BGC101 (EnEPC) is a new treatment being studied for people with a condition called peripheral arterial disease (PAD) that has led to critical limb ischemia (CLI). This condition affects blood flow to the legs and can cause severe pain and other serious problems. BGC101 is being tested to see if it can help improve blood flow and reduce symptoms in patients who have not had success with other treatments, like surgery to improve blood flow. The study aims to find out if BGC101 is safe and effective for these patients.

Autologous Blood-Derived Endothelial Progenitor Cells, Haematopoietic Stem/Progenitor Cells, Activated Dendritic Cells And T Helper Cells

What is already known about the treatment

BGC101 (EnEPC) – BGC101 is administered as an injection and is currently being studied in clinical trials for its potential to treat peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) in patients who have not responded to standard treatments. This medication is in the early stages of research, and its safety and effectiveness are being evaluated. It is designed to help improve blood flow in small blood vessels, which can be crucial for patients who cannot undergo further surgical procedures to restore circulation. BGC101 belongs to a class of treatments that aim to enhance the body's natural ability to repair and regenerate blood vessels.

Investigated diseases

Peripheral Arterial Disease (PAD)
Peripheral Arterial Disease is a condition where the arteries that supply blood to the limbs become narrowed or blocked, usually due to atherosclerosis. This leads to reduced blood flow, primarily affecting the legs. As the disease progresses, individuals may experience pain, cramping, or heaviness in the legs, especially during physical activities like walking. Over time, the symptoms can worsen, leading to pain even at rest. In severe cases, PAD can result in tissue damage or ulcers due to inadequate blood supply. If left untreated, it can lead to complications such as Chronic Limb-Threatening Ischemia.
Chronic Limb-Threatening Ischemia (CLTI)
Chronic Limb-Threatening Ischemia is a severe form of peripheral arterial disease characterized by significantly reduced blood flow to the limbs. This condition results in chronic pain, non-healing wounds, or ulcers on the feet or toes. As the disease advances, the lack of adequate blood supply can lead to tissue death and gangrene. Patients with CLTI often experience persistent pain, even when resting, due to the severe restriction of blood flow. The progression of CLTI can severely impact mobility and quality of life. Without intervention, it can lead to the need for major amputation to prevent further complications.