Cellular Therapy for Bronchopulmonary Dysplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new treatment for bronchopulmonary dysplasia (BPD), a chronic lung disease affecting preterm infants. The treatment uses special cells from umbilical cords (allogeneic umbilical cord tissue-derived mesenchymal stromal cells) that could help improve lung health. Babies born before 28 weeks, who are on ventilators and need extra oxygen, might be suitable candidates for this study. The trial will carefully monitor how different doses of these cells affect these infants. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that using cells from umbilical cord tissue is generally safe. Previous studies found that patients tolerate these cells well. In babies at high risk for bronchopulmonary dysplasia (BPD), administering these cells multiple times proved safe in both the short and mid-term. Another study found these cells safe for people with moderate to severe chronic obstructive pulmonary disease (COPD), suggesting potential safety for other lung issues as well.
Overall, past research supports the safe use of these cells, but ongoing studies will provide more information.12345Why do researchers think this study treatment might be promising?
Most treatments for bronchopulmonary dysplasia, like oxygen therapy and mechanical ventilation, focus on managing symptoms rather than addressing underlying damage. But mesenchymal stromal cell therapy is different because it uses cells derived from umbilical cord tissue that have the potential to repair and regenerate lung tissue. Researchers are excited about this therapy as it targets the root cause of lung injury and inflammation, offering a potentially groundbreaking approach to healing rather than just symptom relief. This new mechanism of action could lead to significant improvements in lung function and overall health outcomes for patients.
What evidence suggests that this treatment might be an effective treatment for bronchopulmonary dysplasia?
Research has shown that special cells from umbilical cords, called mesenchymal stromal cells (MSCs), might help treat bronchopulmonary dysplasia (BPD) in newborns. Early studies suggest these cells can reduce lung inflammation and aid in healing the lungs of premature babies. MSCs adjust the immune system and support tissue repair, which are crucial for managing BPD. Initial findings indicate that using MSCs is generally safe and may improve lung health. In this trial, participants will receive one of three escalating doses of MSCs to further evaluate their safety and effectiveness. However, more research is needed to confirm these benefits.13467
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 born before 28 weeks who are on mechanical ventilation with a high need for oxygen. They must be admitted to specific NICUs and have parents or guardians able to consent. Infants with severe birth defects, active lung complications, heart issues, ongoing shock or sepsis, language barriers in caregivers, expected extubation within 24 hours after treatment, or those not likely to survive are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenously delivered allogeneic uc-MSCs in a dose-escalating manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Safety Follow-Up
Participant's overall health will be assessed through a questionnaire administered over the phone
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic Umbilical Cord Tissue-Derived 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
Ontario Institute of Regenerative Medicine (OIRM)
Collaborator
Stem Cell Network
Collaborator