Active — Not RecruitingPhase 1

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

Canada9 participantsStarted 2022-10-17

Plain-language 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.

Who can participate

Age range7 Days – 28 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence and rate of dose limiting toxicity

Timeframe: Up to 1 week following uc-MSC injection

Trial details

NCT IDNCT04255147

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-06