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Safety Study of Mesenchymal Cells for Preterm Infants with Bronchopulmonary Dysplasia

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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 Bronchopulmonary Dysplasia (BPD), which affects premature babies. BPD is a serious lung condition that can occur in newborns who are born too early and need help breathing. The trial will use a treatment involving Expanded Allogeneic Fetal Umbilical Cord Stem Mesenchymal Cells, which are special cells that may help improve lung health. These cells are given to the patients through a process called intravenous infusion, which means they are delivered directly into the bloodstream.

The purpose of this study is to determine if this treatment is safe for premature babies with BPD. The study will involve giving the treatment to babies who are born at or before 28 weeks of pregnancy and weigh 1250 grams or less. These babies will receive the treatment multiple times over a period of up to six weeks. The researchers will closely monitor the babies for any side effects or reactions to the treatment.

Throughout the study, the health of the babies will be carefully observed, especially their lung condition and overall development. The researchers will also look at how the treatment affects certain markers in the body that are related to inflammation and lung damage. The study aims to provide valuable information about the safety and potential benefits of using these special cells to help treat BPD in premature infants.

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 involves newborns who weigh 1250 grams or less and are born at 28 weeks of gestation or earlier. These newborns must be receiving ventilatory support with a specific oxygen level between days 5 and 14 of life.
Step 2
Treatment administration
The treatment consists of repeated intravenous infusions of expanded allogeneic fetal umbilical cord stem mesenchymal cells. The dosage is 5 million cells per kilogram of the newborn's weight.
The cells are administered as a suspension for IV infusion, which means they are given directly into the bloodstream through a vein.
Step 3
Monitoring and assessment
The primary focus is on assessing the safety of the treatment by monitoring for any adverse reactions.
Secondary assessments include evaluating the status of the newborn at 36 weeks, checking for any lung conditions, and monitoring for other health issues related to prematurity.
Changes in inflammation, oxidative stress, and lung damage markers are also observed, along with variations in respiratory scores during the treatment period and up to 36 weeks.
Step 4
Completion of the study
The study is expected to conclude by June 30, 2027. The final assessments will be conducted to determine the overall safety and feasibility of the treatment.

Who can join the trial?

7 criteria

The patient must be a live newborn.
The newborn must weigh **1250 grams or less**.
The newborn must be born at **28 weeks of gestational age or less**. Gestational age is the time the baby has spent developing in the womb.
The newborn must be on **ventilatory support**, which means they need help to breathe. This can be either invasive (like a tube) or noninvasive (like a mask).
The newborn must require an **oxygen level of 0.3 or higher** in the air they breathe. This is measured by a term called FiO2, which stands for the fraction of inspired oxygen.
The newborn must meet these conditions between **days 5 and 14 of life**.
Both **male and female** newborns can participate.

Who cannot join the trial?

4 criteria

Patients who are not born prematurely.
Patients who do not have bronchopulmonary dysplasia, a lung condition that affects newborns.
Patients who are older than 28 weeks of gestational age. Gestational age is the age of the baby calculated from the mother's last menstrual period.
Patients who weigh more than 1250 grams at birth.

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Verified sites

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain
Verified
Hospital Universitario Marques De Valdecilla
Santander, Spain

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Investigated drugs

UC-MSC is a treatment involving the use of stem cells derived from the umbilical cord. These cells are expanded and then infused into preterm patients. The goal of this therapy is to assess its safety and feasibility for treating bronchopulmonary dysplasia, a lung condition that affects premature infants. The treatment involves repeated intravenous infusions of these stem cells to help improve lung function and overall health in these vulnerable patients.

Mesenchymal Cells

What is already known about the treatment

UC-MSC (Umbilical Cord Mesenchymal Stem Cells) – This medication is administered through intravenous infusions and is currently being studied in a Phase II clinical trial. It is being evaluated for its safety and feasibility in treating premature patients with bronchopulmonary dysplasia, a chronic lung disease. The main therapeutic indication is to support lung development and repair in these patients. At the molecular level, these stem cells are believed to work by modulating the immune response and promoting tissue regeneration. UC-MSCs are classified under cell-based therapies, which are a part of regenerative medicine.

Investigated diseases

Bronchopulmonary Dysplasia – This is a chronic lung disease that primarily affects premature infants who have received oxygen therapy or mechanical ventilation. It occurs when the lungs are not fully developed and become inflamed or damaged. Over time, the condition can lead to scarring and abnormal development of lung tissue. Infants with this condition may experience difficulty breathing, requiring additional oxygen or respiratory support. As the child grows, lung function may improve, but some may continue to have respiratory issues. The severity of the disease can vary, with some infants experiencing mild symptoms and others having more significant respiratory challenges.