Using stem cells from umbilical cords to treat lung disease in premature infants
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants
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 |
| Enrollment | 10 (estimated) |
| Ages | 36 Weeks and up |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06788470 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premature infants born between 23-29 weeks of gestation, weighing between 500-1500 grams, who require ongoing respiratory support.
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.
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 performed: Preclinical studies have shown promise for MSCs in alleviating BPD, suggesting potential for success in this clinical approach.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.