Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells: Cryopreserved allogeneic umbilical cord tissue-derived mesenchymal stromal cells are thawed and administered intravenously.
Study 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.
Eligibility
Sex
ALL
Min age
7 Days
Max age
28 Days
Healthy volunteers
No
A participant needs to meet all inclusion criteria between day of life 7-28 to be eligible:
Inclusion Criteria:
* Admission to The Ottawa Hospital (TOH) NICU - General Campus or Sunnybrook Health Sciences Centre NICU
* Gestational age at birth \< 28 weeks
* Intubated on mechanical ventilation
* Fraction of inspired oxygen ≥ 30%
* Parents or substitute decision make must provide written informed consent
Exclusion Criteria:
* Severe congenital anomaly by antenatal ultrasound and physical examination
* Ongoing shock and severe sepsis (confirmed by positive blood or cerebrospinal fluid culture) as per attending physician
* Severe pulmonary hemorrhage
* Active pneumothorax (with chest tube in-situ)
* Hemodynamically significant PDA
* Participants with caregiver unable to speak English or French
* Patient i moribund, not expected to survive
* Planned to be extubated in the 24 hours after uc-MSC administration
Primary outcome measure(s)
Occurrence and rate of dose limiting toxicity — Up to 1 week following uc-MSC injection Dose limiting toxicity consists of the following events:
* Death occurring within 24 hours of injection;
* Pulmonary embolism defined as acute increase in right ventricular afterload (identified by serial targeted neonatal echocardiography) and signs of acute increased dead space ventilation (respiratory distress, increased PaCO2, increased minute ventilation) occurring within 24 hours of injection;
* Hypersensitivity / anaphylactic to uc-MSCs defined as any severe systemic inflammatory response syndrome with negative blood culture not consistent with the overall clinical course of the infant occurring within 72 hours of injection;
* Any other serious adverse event not expected in this patient population for which there is no alternative explanation but the administration of uc-MSCs, occurring within 1 week of injection.
Trial sites (2)
Facility
City
Region
Status
The Ottawa Hospital - General Campus
Gloucester
Ontario
Sunnybrook Health Sciences Centre
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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