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Study on the Effects of TRI-001 for Patients with Chronic Limb Threatening Ischemia Due to Peripheral Arterial Disease

Verified siteInvestigationalNo placebo

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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 called Chronic Limb Threatening Ischemia (CLTI), which occurs due to Peripheral Arterial Disease (PAD). This condition affects blood flow to the limbs, often leading to severe pain and wounds that do not heal properly. The study is testing a new treatment called TRI-001, which is a type of cell therapy involving allogeneic regulatory macrophages. These are special cells that may help improve healing and blood flow in affected limbs. The treatment is given as a single injection into the muscle.

The purpose of the study is to evaluate the safety and effectiveness of TRI-001 in patients with this condition. Participants will receive either the new treatment or a placebo, which is an inactive substance. The study will monitor the size of the wounds and any changes in the condition over time. The trial will also assess how well patients tolerate the treatment and any side effects that may occur.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their condition. The study aims to see if TRI-001 can help reduce the size of wounds and improve the quality of life for those with Chronic Limb Threatening Ischemia. The trial will last for several months, with the main results expected to be available by 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and assessment
Upon joining the study, you will attend an initial visit where a detailed assessment of your health condition will be conducted. This includes checking your eligibility based on specific criteria related to your condition, chronic limb threatening ischemia (CLTI) due to peripheral arterial disease (PAD).
During this visit, your medical history will be reviewed, and various tests will be performed to ensure you meet the study requirements. These tests may include blood tests, imaging, and other assessments to evaluate your current health status.
Step 2
Randomization and treatment assignment
After the initial assessment, you will be randomly assigned to receive either the study medication, TRI-001, or a placebo. This process is called randomization and ensures that the study results are unbiased.
The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps maintain the integrity of the study results.
Step 3
Administration of study medication
You will receive a single dose of the assigned treatment through an intramuscular injection. This means the medication will be injected into a muscle in your body.
The study medication, TRI-001, is a suspension for injection containing allogeneic regulatory macrophages. The placebo is an inactive substance that looks like the study medication.
Step 4
Follow-up visits and monitoring
After receiving the injection, you will have regular follow-up visits with the study team. These visits are crucial for monitoring your health and the effects of the treatment.
During these visits, various assessments will be conducted, including checking vital signs, performing blood tests, and evaluating the size of the target wound. These assessments help determine the safety and effectiveness of the treatment.
Step 5
Completion of study assessments
The study will continue for a specified period, with the primary endpoint being the safety profile and percentage change in the target wound size at month 12.
Secondary endpoints include the time to complete wound healing, changes in pain scores, and quality of life assessments. These will be evaluated throughout the study duration.
Step 6
End of study participation
At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.
You will be informed about the results of the study and any relevant findings related to your health condition.

Who can join the trial?

13 criteria

Must be a male or female adult, not older than 85 years.
Must have signed an informed consent form, either directly or through a legally authorized representative.
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Must have objective evidence of Chronic Limb Threatening Ischemia (CLTI) due to Peripheral Arterial Disease (PAD) with specific conditions:
- Minor tissue loss without tendon or bone exposure, unless due to a minor amputation.
- Persistent, non-healing ischemic wound(s) present for at least 2 weeks before screening, with at least one wound having a surface area of 3 cm² or more.
- The index leg must meet specific blood flow and metabolic criteria in two exams at least one week apart before randomization.
- Sufficient blood flow in certain arteries as assessed by a Doppler ultrasound at screening.
- No promising conventional treatment options or ineligible for revascularization, confirmed by a committee.
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  Must have adequate organ function:
  - Renal function: Estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m² or more.
  - Hepatic function: Total bilirubin ≤1.5 times the upper limit of normal, and liver enzymes (AST and ALT) ≤3 times the upper limit of normal.
  - Bone marrow: Adequate levels of neutrophils, hemoglobin, and platelets.
  - Must be taking an anti-platelet agent (like clopidogrel, ticlopidine, or aspirin) for 2 weeks or more before randomization, unless contraindicated or on anticoagulants.
  - Patients of reproductive potential must agree to use an accepted and effective form of birth control during the study period.
  - Must be willing and able to complete all study assessments, follow study instructions, and attend all study visits as required.

Who cannot join the trial?

3 criteria

Patients who do not have Chronic Limb Threatening Ischemia (CLTI) due to Peripheral Arterial Disease (PAD).
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population.

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Verified sites

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Technische Universitaet Dresden
Dresden, Germany
Verified
Universitaetsklinikum Duesseldorf AöR
Duesseldorf, Germany
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Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany

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Investigated drugs

TRI-001 is a new treatment being tested for people with a condition called chronic limb-threatening ischemia, which is a severe form of poor blood flow in the legs. This condition is often caused by peripheral arterial disease, where the arteries in the legs become narrowed or blocked. The treatment involves injecting TRI-001 directly into the muscles. The main goal of this treatment is to see if it is safe for patients and if it can help reduce the size of wounds caused by the poor blood flow. By improving blood flow, TRI-001 aims to help heal these wounds and improve the overall health of the affected limb.

ALLOGENEIC REGULATORY MACROPHAGES

What is already known about the treatment

TRI-001 – TRI-001 is administered through an injection directly into the muscle, known as intramuscular injection. It is currently being studied in clinical trials to assess its safety and effectiveness for patients with Chronic Limb Threatening Ischemia (CLTI) caused by Peripheral Arterial Disease (PAD). The main goal of TRI-001 is to help reduce the size of wounds in affected patients. At the molecular level, TRI-001 works by targeting specific pathways to improve blood flow and promote healing in the limbs. It is classified under experimental therapies as it is still in the early stages of clinical research.

Investigated diseases

Chronic Limb Threatening Ischemia – Chronic Limb Threatening Ischemia is a severe form of Peripheral Arterial Disease. It occurs when there is a significant reduction in blood flow to the limbs, usually the legs, due to narrowed or blocked arteries. This condition leads to symptoms such as severe pain, even at rest, and non-healing wounds or ulcers on the feet or legs. Over time, the lack of adequate blood supply can cause tissue damage and increase the risk of infections. If left unaddressed, it can result in the deterioration of the affected limb's function. The progression of this disease can lead to complications that may require medical intervention to prevent further damage.