Mesenchymal Stromal Cell Therapy for Bronchopulmonary Dysplasia
(HULC-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether mesenchymal stromal cell therapy, using cells from umbilical cords, can prevent lung problems in extremely premature babies. The goal is to determine if these cells can improve breathing and reduce other issues associated with premature birth. Babies in this trial will either receive the cell therapy through an IV or undergo a sham procedure that mimics the treatment without delivering it. This trial is suitable for babies born before 28 weeks who require ventilator support and have a higher oxygen requirement (30% or more) over 12 hours. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
In a previous study, researchers found that using cells from umbilical cords is safe. Patients with lung issues like chronic obstructive pulmonary disease (COPD) tolerated these cells well. Another study showed that repeated doses of these cells were safe for very young babies at risk of lung disease in the short- and mid-term.
This treatment uses cells from donated umbilical cords, administered through an IV, similar to receiving medicine through a small tube into a vein. So far, these studies suggest that the cells cause few, if any, serious side effects. This is a promising sign for their safety in other conditions, such as lung problems in premature babies.12345Why do researchers think this study treatment might be promising for bronchopulmonary dysplasia?
Researchers are excited about using Human Allogenic Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs) for treating Bronchopulmonary Dysplasia because they offer a unique approach compared to current treatments. Unlike standard options that mainly focus on managing symptoms with medications like corticosteroids and diuretics, UC-MSCs work by potentially regenerating lung tissue and reducing inflammation at a cellular level. This new mechanism of action targets the root cause of the condition rather than just alleviating its symptoms. Additionally, the treatment is administered via a simple IV infusion, making it less invasive and potentially more accessible for infants suffering from this condition.
What evidence suggests that this treatment might be an effective treatment for bronchopulmonary dysplasia?
Research has shown that special cells from human umbilical cords, called mesenchymal stromal cells (MSCs), might help treat lung problems like bronchopulmonary dysplasia (BPD). Studies have found that these cells can repair lung damage and improve lung development in premature babies. In this trial, participants in the intervention group will receive multiple IV doses of MSCs. Early results suggest that administering these cells through an IV is safe and may reduce serious lung issues. Other research indicates that using these cells for lung diseases is becoming more common in medicine. Therefore, there is hope that MSC therapy could help with breathing problems in premature infants.23467
Who Is on the Research Team?
Bernard Thébaud, MD, PhD
Principal Investigator
Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for extremely preterm infants at risk of developing bronchopulmonary dysplasia, a lung condition. The study includes those who meet specific medical criteria and excludes certain health conditions that could interfere with the trial's safety or results.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly intravenous doses of UC-MSCs or undergo a sham procedure for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including respiratory support and complications of prematurity
Long-term follow-up
Annual parental interviews via telephone to assess respiratory status and new diagnoses until the participant is 10 years old
What Are the Treatments Tested in This Trial?
Interventions
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Stem Cell Network
Collaborator