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.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 36 Weeks and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | August 9, 2024 |
| Main results expected | August 9, 2027 |
| Study ends | August 9, 2027 |
| Registry record updated | January 23, 2025 |
| Trial ID | NCT06788470 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
- Study coordinator: Yaoqin Hu, MD
- Email: huyaoqin@zju.edu.cn
- Phone: 0571-86670704
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Higher zinc supplementation to boost weight gain in extremely premature infants
This study tests whether giving preterm babies a higher daily dose of zinc helps them gain weight faster than the current dose.
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Remote-controlled oxygen therapy for preterm infants with BPD
This project will test whether remote monitoring and protocol-driven adjustments of home oxygen can safely help preterm infants with bronchopulmonary dysplasia stop oxygen sooner.
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Identifying early MRI markers for lung issues in extremely preterm infants
This study is testing if early MRI scans can help predict lung problems in extremely preterm infants to improve their care and treatment.
-
Evaluating L-Citrulline for Preterm Infants with Lung and Gut Issues
This study is testing if giving L-Citrulline to preterm infants with lung and gut problems can help reduce inflammation and improve their health.
-
Enteral DHA and ARA Supplementation for Very Preterm Infants with BPD Risk
This study tests whether giving a specific mix of DHA and ARA through feeding helps prevent bronchopulmonary dysplasia in extremely and very preterm babies.
-
Continuing CPAP protection for extremely preterm babies to reduce BPD or death
This study tests whether keeping CPAP up to 34 weeks' PMA or for at least 2 more weeks, instead of weaning to a nasal cannula, lowers the chance of bronchopulmonary dysplasia or death by 36 weeks' PMA in babies born before 29 weeks gestation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.