Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 36 Weeks and up

Using stem cells from umbilical cords to treat lung disease in premature infants

Official title: Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants

Run by The Children's Hospital of Zhejiang University School of Medicine · NCT06788470 · Data updated 2026-11-12

This study is testing whether using stem cells from umbilical cords can help improve lung health in premature infants with a serious lung condition called bronchopulmonary dysplasia.

More Bronchopulmonary Dysplasia (BPD) trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages36 Weeks and up
SexAll
Enrollment10 (estimated)
SponsorThe Children's Hospital of Zhejiang University School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedAugust 9, 2024
Main results expectedAugust 9, 2027
Study endsAugust 9, 2027
Registry record updatedJanuary 23, 2025
Trial IDNCT06788470 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are premature infants born between 23-29 weeks of gestation, weighing between 500-1500 grams, who require ongoing respiratory support.

Probably not a fit

Patients with severe congenital heart disease or other significant complications such as intraventricular hemorrhage above level 3 may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of umbilical cord-derived mesenchymal stem cell (MSC) transplantation for treating bronchopulmonary dysplasia (BPD) in premature infants. BPD is a serious lung condition that affects very low and ultra-low birth weight infants, leading to long-term health issues. The study aims to assess whether MSCs can improve lung function and reduce inflammation in these infants who have not responded to standard treatments. Participants will be closely monitored for improvements in their lung condition and overall health.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for premature infants suffering from BPD.

How similar studies have gone: Preclinical studies have shown promise for MSCs in alleviating BPD, suggesting potential for success in this clinical approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. 23-29 weeks of gestation, birth weight 500-1500g;
2. For patients with no improvement or aggravation of lung condition after DART hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks.
3. Children with severe BPD after early use of PS
4. Parents agree to participate in clinical trials.

Exclusion Criteria:

1. Premature infants not suitable for the given gestational age;
2. Other congenital structural malformations of trachea, bronchus and lungs;
3. Complicated with severe congenital heart disease;
4. Complicated with Periventricular Leukomalacia (PVL);
5. Complicated with intraventricular hemorrhage (IVH) above level 3;
6. Septic shock or positive blood culture;
7. Acute pulmonary hemorrhage;
8. Intracranial and extracranial diseases affecting respiratory rate and rhythm.

Where it's running

  • The Children's Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.