Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia
This study is investigating a new way to help very premature babies who are at risk of developing a serious lung condition called bronchopulmonary dysplasia (BPD). BPD can cause long-term breathing problems. Researchers are using special cells, called mesenchymal stromal cells (MSCs), taken from umbilical cord tissue. These cells have shown promise in laboratory studies for helping lungs grow and repair. The main goal of this first-phase study is to make sure this cell treatment is safe for these vulnerable babies. They also want to find out the best amount, or 'dose', of these cells to give. This research offers hope for a new way to protect the lungs of extremely premature infants.
At a glance
What is this study about?
Bronchopulmonary dysplasia (BPD) is a common and serious lung condition that can affect babies born very prematurely. It often happens when premature babies need help breathing with a ventilator and extra oxygen. BPD can lead to long-term health problems, including difficulties with breathing and development. Unfortunately, there isn't a really effective treatment for BPD right now, and doctors are always looking for better ways to help these babies.
This study is exploring a new treatment idea using special cells called mesenchymal stromal cells (MSCs). These MSCs come from the tissue of umbilical cords after a baby is born. Previous research, mainly in laboratories and animal studies, suggests that these cells might have several helpful effects. They could help protect the tiny, developing lungs from damage and encourage them to grow.
The main purpose of this study, which is an early-stage 'Phase 1' trial, is to check if giving these umbilical cord-derived MSCs to extremely premature babies at risk of BPD is safe. Researchers also want to find out the best and most appropriate amount, or 'dose', of these cells to give. By carefully studying this, they hope to pave the way for future research into potentially effective treatments for BPD.
Key takeaways
- This study explores a new cell treatment for a serious lung condition (BPD) in very premature babies.
- The treatment uses special cells from umbilical cord tissue.
- The main goal is to check if the treatment is safe and to find the correct dose.
- BPD can cause long-term breathing problems, and new treatments are urgently needed.
- Participation is only for specific very premature infants in certain hospitals.
- Parents considering participation will receive full details from the study team.
Who may be eligible?
This study is looking for very premature babies who meet specific health conditions and are between 7 and 28 days old. They must have been born before 28 weeks of pregnancy and be in the intensive care unit at The Ottawa Hospital or Sunnybrook Health Sciences Centre.
Babies might be able to join if they are currently on a breathing machine (ventilator) and need at least 30% oxygen to help them breathe. Importantly, parents or legal guardians must be able to give written permission for their baby to take part.
Some conditions would prevent a baby from joining the study. This includes having serious birth defects, severe ongoing infections, serious bleeding in the lungs, collapsed lungs needing a chest tube, or specific heart problems. Also, babies who are extremely unwell and not expected to survive, or whose parents don't speak English or French, would not be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your baby 7 to 28 days old?
- Was your baby born before 28 weeks of pregnancy?
- Is your baby currently on a breathing machine (ventilator)?
- Does your baby need at least 30% oxygen to breathe?
- Are you able to provide written consent and speak English or French?
- Does your baby have any of the listed serious health conditions that would prevent participation?
What does participation involve?
This is an early-stage study, so the focus is on safety. If your baby is eligible and you agree for them to participate, they would receive a dose of the special cells through a vein. The doctors will then carefully monitor your baby's health very closely. This could involve regular checks of their breathing, heart rate, and other vital signs, as well as blood tests and other examinations. The study aims to find the safest dose, so babies might receive different amounts of cells. The exact number of visits and tests would be discussed in detail by the study team, along with the total time your baby would be followed for the purpose of the study. This information will be fully explained before you make any decisions.
Potential risks and benefits
Locations (2)
- The Ottawa Hospital - General CampusVerified postcodeGloucester, Canada
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
Common questions
What is Bronchopulmonary Dysplasia (BPD)?
BPD is a chronic lung condition that affects premature babies, often when they've needed help breathing with a ventilator and oxygen.
What are Mesenchymal Stromal Cells (MSCs)?
MSCs are special cells, in this study taken from umbilical cord tissue, that researchers hope can help repair and protect the lungs.
Is this a new treatment?
Yes, this is an early-stage study to see if this cell therapy is safe for premature babies at risk of BPD. It's not yet a standard treatment.
Where do the cells come from?
The cells used in this study come from the umbilical cord tissue of healthy babies after birth, with permission from their parents.
What is a 'Phase 1' study?
A Phase 1 study is the first step in testing a new treatment in people. Its main goal is to check for safety and find the right dose.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.