Canadian Phase 2 Trial • Health Canada Approved
BACKGROUND
Understanding HULC-2
Learn about premature lung development, bronchopulmonary dysplasia (BPD), and the research exploring new ways to support babies’ growing lungs.
Extreme preterm birth
If your baby was born before 28 weeks of pregnancy, they are considered an extremely low gestational age (ELGA) infant. These babies are incredibly resilient, but they face unique challenges because their organs, especially their lungs and brains, are still developing. Thanks to advances in neonatal care, many ELGA babies survive and thrive. However, their journey often includes time in the NICU and ongoing medical support.
As a parent, this can be an emotional and overwhelming experience. You may be facing uncertainty, making difficult decisions, and hoping for the best outcomes for your little one. The HULC-2 study is designed to explore new ways to support these babies during their most vulnerable time.
What is bronchopulmonary
dysplasia (BPD)?
One of the most common and serious complications for ELGA infants is Bronchopulmonary Dysplasia (BPD). BPD is a chronic lung condition that can develop when a baby’s lungs are not fully formed and need help from machines and oxygen to breathe. While these treatments are essential, they can also cause stress and inflammation in the lungs.
BPD can lead to long-term breathing problems, frequent infections, and even affect brain development. Right now, there is no cure, only supportive treatments like medications and careful monitoring. The goal of the HULC-2 study is to find a new way to help babies’ lungs heal and grow, potentially reducing the impact of BPD.
What are mesenchymal stromal cells (MSCs)?
Mesenchymal Stromal Cells (MSCs) are special cells found in places like bone marrow and umbilical cords. These cells have natural healing properties; they can calm inflammation, support tissue repair, and help organs grow. Scientists believe MSCs work by releasing helpful substances that encourage healing, rather than becoming part of the tissue themselves.
In early research, MSCs have shown promise in helping protect and repair the lungs in newborn animals. They help reduce inflammation, promote lung growth, and improve lung function. Clinical trials in adults and children have shown that MSCs are generally well tolerated, with few side effects.
What we know so far
Before launching the HULC-2 trial, researchers conducted extensive laboratory and animal studies
to understand how MSCs might help fragile newborn lungs. In neonatal rat models of BPD, MSCs
were shown to:
In another study using a large experimental model mimicking extremely prematurity lung development (similar to human babies born at 24 weeks), MSCs were safely given through an IV. The treatment did not cause any immediate side effects, and the cells did not remain in the body long-term (5).
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In addition, MSCs may also help protect against infection, as Dr. Thébaud and his team showed in a study that UC-MSCs improved survival and bacterial clearance in a neonatal sepsis model (6), and they may even provide neuroprotective effects, supporting the development of the immature brain (7).
These findings gave researchers confidence to move forward with human studies. The HULC-1 trial (NCT04255147), which tested a single dose of MSCs in ELGA infants, found no serious side effects. Building on this, the HULC-2 trial (NCT07058025) will explore whether giving three doses of MSCs over three weeks can help babies spend fewer days on mechanical ventilation. The HULC-2 protocol was recently published (8).
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Families will be supported throughout the process, and babies will be followed closely for up to 10 years to monitor their health and development. The HULC-2 team is committed to ensuring the highest standards of safety, transparency, and care. Our hope is that this research will lead to better outcomes for ELGA infants.
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