drugset / Trial / NCT04255147
Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia
Phase 1
Active not recruiting
9 enrolled
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR) · collabOntario Institute for Regenerative Medicine · collabStem Cell Network · collab
NaSingle-groupOpen-labelPrevention
Summary
Bronchopulmonary dysplasia (BPD) is a common and chronic lung disease that occurs in preterm infants following ventilator and oxygen therapy and is associated with long-term health consequences. Preclinical research shows that mesenchymal stromal cells (MSCs) can modify a number of pathophysiological processes that are central to the progression of BPD and thus present as a promising new treatment option. The main purpose of this Phase I study is to evaluate the safety of human umbilical cord tissue-derived MSCs in extremely preterm infants at risk of developing BPD.
Timeline
- Start
- 2022-10-17
- Primary completion
- 2023-11-06
- Completion
- 2033-11-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells | Cell therapy | 1 cells/kg | Intravenous |
| Subject | Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells | Cell therapy | 3 cells/kg | Intravenous |
| Subject | Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells | Cell therapy | 10 cells/kg | Intravenous |