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ACTIVE NOT RECRUITING
NCT04255147
PHASE1

Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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.

Official title: Helping Underdeveloped Lungs With Cells (HULC): Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - Phase 1 Study

Key Details

Gender

All

Age Range

7 Days - 28 Days

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2022-10-17

Completion Date

2033-11-06

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells

Cryopreserved allogeneic umbilical cord tissue-derived mesenchymal stromal cells are thawed and administered intravenously.

Locations (2)

The Ottawa Hospital - General Campus

Gloucester, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada