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ALLOGENEIC REGULATORY MACROPHAGES

Clinical trials are investigating ALLOGENEIC REGULATORY MACROPHAGES in people with chronic limb threatening ischemia due to peripheral arterial disease. These studies aim to assess safety, tolerability, and possible effects on wound healing in affected patients. One trial is in Phase 1/2 and includes a placebo comparator.

Table of Contents

Trial overview

The available study of ALLOGENEIC REGULATORY MACROPHAGES is titled “Effect of TRI-001 in patients with chronic limb threatening ischemia.”[1] It is an interventional trial, which means researchers are giving a study treatment and then measuring the results.[1]

The trial is authorised and is planned for 52 participants.[1] The study is in Phase 1/2, so it is still in an early stage of clinical research.[1]

Who is being studied

The target population is patients with chronic limb threatening ischemia (CLTI) due to peripheral arterial disease (PAD).[1] CLTI is a severe form of poor blood flow to the limb, and PAD is a disease where narrowed arteries reduce blood flow.[1]

The brief summary shows that the study is focused on people who have this condition and a target wound that can be followed over time.[1]

What the studies measure

The main goal is to evaluate the safety profile of intramuscularly injected TRI 001, which includes checking for adverse events and clinically important changes in safety tests.[1] Safety checks include vital signs, 12-lead ECG, safety laboratory testing such as biochemistry, haematology, and urinalysis, plus other disease-related safety measures.[1]

The study also measures the percentage change from baseline in the target wound size at Month 12.[1] Baseline means the starting point before treatment begins, so this outcome shows whether the wound becomes smaller over time.[1]

The brief summary also states that the study is checking tolerability, which means how well patients can receive the treatment without major problems.[1]

Trial design and treatment groups

The interventions listed are a placebo comparator given by intramuscular injection and TRI 001 given by intramuscular injection.[1] A placebo comparator is an inactive treatment used for comparison so researchers can judge the study treatment more clearly.[1]

This design helps researchers compare outcomes between the active study treatment and the placebo group.[1]

Study phase and size

Because the trial is Phase 1/2, it combines early safety testing with an early look at possible benefit.[1] Trials of this type are often smaller than later studies, and this one plans to enroll 52 people.[1]

The study type is interventional, which means the research team actively gives the treatment rather than only observing patients.[1]

What the results may mean for patients

For patients with CLTI due to PAD, this trial is mainly about whether ALLOGENEIC REGULATORY MACROPHAGES can be studied safely and whether it may help with wound healing.[1] The key patient-focused outcomes are safety, tolerability, and change in the target wound size at 12 months.[1]

At this stage, the study does not prove benefit; it is designed to learn whether the treatment is promising enough for further research.[1]

Trial ID Phase Condition studied Status Enrollment
2024-517765-16-00 Phase 1/2 Chronic Limb Threatening Ischemia due to Peripheral Arterial Disease Authorised 52

FAQ

  • What are the ALLOGENEIC REGULATORY MACROPHAGES trials studying? The trial is studying whether ALLOGENEIC REGULATORY MACROPHAGES can be given safely and whether it may help reduce target wound size in chronic limb threatening ischemia. It also compares the study treatment with a placebo comparator.
  • Who may be able to join these trials? The trial data describe patients with chronic limb threatening ischemia due to peripheral arterial disease. Participation is focused on this target group.
  • What phase is the trial? The trial is a Phase 1/2 study. This means it is looking at early safety and also beginning to explore whether the treatment may work.
  • What outcomes are being measured? The main outcomes are safety and change in target wound size at Month 12. Safety includes adverse events and changes in vital signs, ECG, laboratory tests, urinalysis, and other disease-related safety measures.
  • How many people are planned for the study? The planned enrollment is 52 participants. This is a relatively small study, which is common in early-phase clinical research.

Ongoing Clinical Trials on ALLOGENEIC REGULATORY MACROPHAGES

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

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Chronic Limb Threatening Ischemia (CLTI): A serious condition where poor blood flow to the leg or foot can lead to pain, wounds, or tissue damage.
  • Peripheral Arterial Disease (PAD): A disease in which the arteries in the legs become narrowed, reducing blood flow.
  • Placebo comparator: An inactive treatment used for comparison so researchers can see whether the study treatment works better than no active treatment.
  • Intramuscular injection: An injection given into a muscle.
  • Phase 1/2: An early stage of clinical research that looks at safety first and also starts to check for signs that the treatment may help.
  • Adverse Events (AEs): Any unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Vital signs: Basic body measurements such as blood pressure, pulse, temperature, and breathing rate.
  • ECG: A heart test called electrocardiogram that records the heart's electrical activity.
  • Safety laboratory testing: Blood and urine tests used to check how the body is responding to the study treatment.
  • Target wound size: The main wound being measured in the study to see if it gets smaller over time.

References

  1. https://clinicaltrials.gov/study/2024-517765-16-00