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Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants

ConditionsBronchopulmonary Dysplasia (BPD)ELGAN (22-28SA)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-14
SponsorOttawa Hospital Research Institute

About this trial

This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.

Study participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age (GA) less than 28+0 weeks

Post-natal age between 4 and 14 days of life

With requirement of FiO2: FiO2 >= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)

Disqualifiers

Genetic and chromosomal syndromes (e.g., Trisomy 13, Trisomy 18, Trisomy 21): either patient with high suspicion (antenatal findings, clinical features) or documented syndrome by genetic testing.

Major congenital anomalies including cardiac (i.e., congenital heart defects, NB. PDA is not considered an exclusion criterion), neurological (e.g., holoprosencephaly, anencephaly), gastrointestinal (e.g., gastroschisis, omphalocele), pulmonary (e.g., congenital diaphragmatic hernia) anomalies.

Inborn errors of metabolism.

Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and/or decreased urine output).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human Allogenic Umbilical Cord Mesenchymal Stromal Cells

    Biological/Vaccine

    IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded

  • Sham procedure control

    Other intervention

    Sham procedure (mimic IV catheter insertion adn cell product infusion behing a screen). Repeated weekly for 3 weeks

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Intervention group will receive multiple IV doses of UC-MSCsExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of mechanical ventilation-free days accounting for mortality

The study primary outcome is the number of mechanical ventilation-free days accounting for mortality. Mechanical ventilation is defined by artificial ventilation using an endotracheal tube. For study purpose, this outcome will be measured at 120 days after randomization. To account for mortality, any death within 120 days post randomization will be counted as "0" mechanical ventilation-free day (worse outcome).

Time frame
120 days

Secondary outcomes

1

Effects of uc-MSCs on the date of extubation for participants.

This respiratory outcome will be measured to determine if uc-MSCs have an effect on the date of extubation for participants

Time frame
From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months
2

Effects of uc-MSCs on the rate of survival without moderate or severe BPD at 36 weeks corrected age.

This will assess if uc-MSCs impact survival with moderate or severe Bronchopulmonary dysplasia.

Time frame
BPD severity will be assessed for each participant at 36 weeks of corrected age
3

Effects of uc-MSCs on the Number of Participants receiving open-label dexamethasone for severe chronic lung disease

This will help us determine if the intervention reduces use of dexamethasone for the treatment of severe chronic lung disease.

Time frame
From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months
4

Effects of uc-MSCs on the duration of respiratory support.

Since ventilation damages underdeveloped lungs, determining the duration of ventilation is important to monitor as an outcome of uc-MSCs. We will collect the total number of days on mechanical ventilation, non-invasive ventilation, and oxygen therapy during the NICU hospitalization for each participant

Time frame
From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Stem Cell Network

Collaborator

Source ClinicalTrials.gov

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