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Mesenchymal Stromal Cells

Cellular Therapy for Bronchopulmonary Dysplasia

Phase 1

Waitlist Available

Led By Bernard Thébaud, MD, PhD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intubated on mechanical ventilation

Fraction of inspired oxygen ≥ 30%

Must not have

Hemodynamically significant PDA

Ongoing shock and severe sepsis (confirmed by positive blood or cerebrospinal fluid culture) as per attending physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ten years following follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if it is safe to give human mesenchymal stromal cells (MSCs) to extremely preterm infants who are at risk of developing bronchopulmonary dysplasia (BPD).

Who is the study for?

This trial is for extremely preterm infants born before 28 weeks who are on mechanical ventilation with a high need for oxygen. They must be admitted to specific NICUs and have parents or guardians able to consent. Infants with severe birth defects, active lung complications, heart issues, ongoing shock or sepsis, language barriers in caregivers, expected extubation within 24 hours after treatment, or those not likely to survive are excluded.

What is being tested?

The study tests the safety of using cells from umbilical cord tissue (called mesenchymal stromal cells) in very early-born babies at risk of developing a chronic lung disease known as Bronchopulmonary Dysplasia. It's an initial phase trial aimed at seeing if this new therapy is safe for these vulnerable infants.

What are the potential side effects?

As it's a Phase I safety trial primarily assessing the risks of administering mesenchymal stromal cells to premature infants, potential side effects may include reactions at the infusion site or immune responses; however detailed side effect profiles will be determined by this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on a breathing machine.

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I am on oxygen therapy with at least 30% oxygen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant heart defect known as PDA.

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I am currently experiencing severe shock and infection, confirmed by tests.

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I have had severe bleeding in my lungs.

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My caregiver does not speak English or French.

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I currently have a chest tube for a collapsed lung.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ten years following follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ten years following follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and ten years following follow-up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence and rate of dose limiting toxicity

Secondary study objectives

Animated Information Video

Bayley Scale of Infant and Toddler Development

Biological Measure of Clinical Improvement

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mesenchymal Stromal Cell TherapyExperimental Treatment1 Intervention

Patients are enrolled into one of three escalating dose panels based on the time of enrolment. The first three patients will receive 1 million cells/kg of body weight, the next three patients will receive 3 million cells/kg of body weight, and the final three patients will receive 10 million cells/kg of body weight. Progression through the escalating dose panels is subject to review by an independent Data Safety Monitoring Committee.

0 / 7Eligibility criteria met