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Mesenchymal Stromal Cells

Cellular Therapy for Bronchopulmonary Dysplasia

Phase 1

Recruiting

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ten years following follow-up visit

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence and rate of dose limiting toxicity

Secondary outcome measures

Animated Information Video

Bayley Scale of Infant and Toddler Development

Biological Measure of Clinical Improvement

+14 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,685 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,758 Total Patients Enrolled

4 Trials studying Bronchopulmonary Dysplasia

3,663 Patients Enrolled for Bronchopulmonary Dysplasia

Ontario Institute of Regenerative Medicine (OIRM)UNKNOWN

Media Library

Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04255147 — Phase 1

Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255147 — Phase 1

Bronchopulmonary Dysplasia Research Study Groups: Mesenchymal Stromal Cell Therapy

Bronchopulmonary Dysplasia Clinical Trial 2023: Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells Highlights & Side Effects. Trial Name: NCT04255147 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults over the age of 18 being enrolled in this investigation?

"This particular medical study is restricted to infants aged 7 days through 21 days. For those under 18 and over 65, there are 74 trials available for the former group and 136 studies open for enrollment to the latter age range."

Answered by AI

Am I eligible to join the experiment?

"This trial needs 9 infants, aged between 7 Days and 21 Days, who possess bronchopulmonary dysplasia. Additionally, the participants must have been birthed before 28 weeks gestation, recently intubated to a mechanical ventilator, and admitted into The Ottawa Hospital General Campus Neonatal Intensive Care Unit."

Answered by AI

Is this study currently enlisting participants?

"As per the current records published on clinicaltrials.gov, this medical trial is not currently recruiting patients. Initially posted on October 1st 2022 and updated lastly on October 7th 2022 , no further recruitment of participants are required at present; however, 210 other studies have open patient enrolment opportunities available now."

Answered by AI

In what numbers is this experiment recruiting participants?

"Sadly, this trial is no longer recruiting. The posting was put up on October 1st 2022 and the last update occured on October 7th 2022. There are 177 studies searching for volunteers battling bronchopulmonary dysplasia, as well as 33 trials seeking participants to receive allogeneic umbilical cord tissue-derived mesenchymal stromal cells treatments."

Answered by AI

Has the FDA sanctioned Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for therapeutic use?

"Considering the limited data available to us, our team at Power has cautiously assigned Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells a score of 1 for safety. This is in line with its classification as a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04255147.

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