RecruitingRare disease

Study on the Safety and Effect of EXOB-001 in Preventing Bronchopulmonary Dysplasia in Extremely Preterm Newborns

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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 Bronchopulmonary Dysplasia (BPD), which affects the lungs of extremely preterm newborns. The trial is investigating a new treatment called EXOB-001, which is made from special particles derived from umbilical cord cells. These particles are known as extracellular vesicles and are believed to help in preventing BPD. The study will also use a saline solution, which is a simple saltwater solution, as a comparison.

The purpose of the study is to assess the safety and effectiveness of EXOB-001 in preventing BPD in newborns who are born very early. The study is divided into two phases. In the first phase, the focus is on understanding the immediate and short-term safety of the treatment when given through the windpipe. In the second phase, the study will look at how well the treatment works in reducing the severity of BPD compared to the saline solution.

Participants in the study will receive the treatment through a method called intratracheal administration, which means it is delivered directly into the windpipe. The study will monitor the newborns until they reach 36 weeks of what is called postmenstrual age, which is the age of the baby calculated from the mother's last menstrual period. The trial aims to find out if EXOB-001 can help reduce the severity of BPD and improve the health outcomes of these vulnerable newborns.

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
Enrollment
Upon joining the clinical trial, the newborn will be enrolled based on specific criteria. These include being born between 23 and 28 weeks of gestation, having a birth weight between 500g and 1500g, and requiring mechanical ventilation.
The parents or legally designated representative must provide written informed consent for participation in the trial.
Step 2
Phase I treatment
In phase I, the newborn will receive an intratracheal administration of EXOB-001, which is derived from umbilical cord cells. This is done to assess the safety of the treatment.
The treatment may involve a single dose or multiple doses at different levels, and the newborn will be monitored for any immediate or short-term side effects up to 36 weeks postmenstrual age.
Step 3
Phase I monitoring
During this phase, the newborn will undergo various assessments to monitor for any treatment-emergent adverse events. This includes clinical examinations, blood tests, lung ultrasounds, chest X-rays, and echocardiography.
The need for oxygen and ventilation support will be evaluated, and any serious adverse reactions will be documented.
Step 4
Phase II treatment
In phase II, the newborn will be part of a randomized, placebo-controlled study to assess the efficacy of EXOB-001 in reducing the severity of bronchopulmonary dysplasia (BPD).
The newborn will receive either the EXOB-001 treatment or a placebo, which is a saline solution, and the effects will be compared.
Step 5
Phase II monitoring
The newborn will continue to be monitored for any adverse events and the need for oxygen and ventilation support. The incidence and severity of BPD will be assessed at 36 weeks postmenstrual age.
Additional assessments will include clinical examinations, blood tests, lung ultrasounds, chest X-rays, and echocardiography.
Step 6
Completion
Upon completion of the trial, the newborn's health and development will be evaluated to determine the overall safety and efficacy of the treatment.
The trial is expected to conclude by June 2028, and the results will contribute to understanding the potential benefits of EXOB-001 in preventing bronchopulmonary dysplasia in extremely preterm newborns.

Who can join the trial?

6 criteria

From birth up to 10 days old.
Born between 23 weeks and 28 weeks (27 weeks and 6 days) of pregnancy.
Birth weight between 500 grams and 1500 grams.
Currently using a breathing tube and receiving help from a machine to breathe, with oxygen levels greater than 25% anytime between 3 and 10 days after birth, or needing the breathing tube again due to breathing problems.
Not expected to have the breathing tube removed within the next 24 to 48 hours after joining the study.
Written permission from parents or legally authorized representative.

Who cannot join the trial?

4 criteria

Patients with a history of **Bronchopulmonary Dysplasia** cannot participate. This is a lung condition that affects newborns, especially those who were born prematurely.
Patients who are not within the specified age range for the study are excluded. The study is designed for a specific age group.
Patients who do not meet the gender criteria for the study are excluded. The study includes both male and female participants.
Patients who are considered part of a **vulnerable population** are excluded. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children or those with certain health conditions.

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Verified sites

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Verified
Az St-Jan Brugge-Oostende A.V.
Brugge, Belgium
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

Trial locations

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Investigated drugs

EXOB-001 is a treatment being tested in this clinical trial. It is made from tiny particles called extracellular vesicles, which are derived from cells found in umbilical cords. These vesicles are thought to have special properties that might help protect the lungs of very premature newborns. The treatment is given directly into the windpipe to see if it can prevent a lung condition called bronchopulmonary dysplasia, which is common in extremely preterm babies. The trial is looking at how safe this treatment is and whether it can effectively reduce the severity of this lung condition compared to a simple saltwater solution.

What is already known about the treatment

EXOB-001 – This medication is administered directly into the windpipe (intratracheal administration) and is being studied for its potential to prevent a lung condition called bronchopulmonary dysplasia in very premature newborns. Currently, it is in the clinical trial phase, where researchers are examining its safety and effectiveness. The main therapeutic use being explored is to reduce the severity of this lung condition in newborns. At the molecular level, EXOB-001 works by using tiny particles derived from umbilical cells to potentially repair and protect lung tissue. It falls under the pharmacological classification of cell-derived therapies.

Investigated diseases

Bronchopulmonary Dysplasia – Bronchopulmonary Dysplasia is a chronic lung disease that primarily affects premature infants who have received oxygen therapy or mechanical ventilation. It is characterized by inflammation and scarring in the lungs. The disease progresses as the infant's lungs develop abnormally, leading to breathing difficulties and reduced lung function. Over time, affected infants may experience episodes of wheezing, coughing, and increased respiratory effort. As the child grows, the symptoms may improve, but some may continue to have respiratory issues into childhood. The severity of the disease can vary, with some infants experiencing mild symptoms and others requiring prolonged respiratory support.