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Study on the safety and efficacy of umbilical cord mesenchymal stem cell transplantation for the treatment of bronchopulmonary dysplasia in premature infants

Study on the safety and efficacy of umbilical cord mesenchymal stem cell transplantation for the treatment of bronchopulmonary dysplasia in premature infants

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087784
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-12
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchopulmonary dysplasia

Interventions

control group:None
low-dose group:Intratracheal infusion of MSCs 1 × 10 ^ 7/kg
high-dose group :Intratracheal infusion of MSCs 2 × 10 ^ 7/kg

Sponsors

Children's Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. gestational weeks 23-29, birth weight 500-1500g 2. no change or exacerbation after DART therapy and need positive pressure ventilation or FiO2>0.3 until 36 of corrected gestational weeks 3. severe BPD and used PS after birth 4. parents of the patients agree to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. preterm, small for gestational age 2. maldevelopment deformity of trachea, bronchus and lung, inherited metabolic diseases 3. severe congenital heart disease 4. PVL 5. IVH over 3 class 6. severe sepsis 7. acute pneumorrhagia 8. Intracranial and extracranial diseases that affect respiratory rate and rhythm: Severe cranial diseases such as severe intracranial infections, intracranial tumors, severe brain injury after asphyxia, congenital central hypoventilation syndrome, etc. cause respiratory center dysfunction, while neuromuscular diseases such as Guillain-Barre Syndrome, congenital muscle weakness, diaphragmatic motor disorders, etc. cause respiratory muscle dysfunction; 9. Maternal use of hormones during pregnancy and congenital intrauterine infections.

Design outcomes

Primary

MeasureTime frame
anaphylaxis;Infection situation;mortality;Tracheal intubation time;

Secondary

MeasureTime frame
Inflammatory factors;Oxygenation index;Respiratory system severity score;

Countries

China

Contacts

Public ContactShu Qiang

Children's Hospital Affiliated to Zhejiang University School of Medicine

huyaoqin@zju.edu.cn+86 139 0650 0193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026