NCT03873506

Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 1 Month – 5 Years
• Healthy volunteers: Not accepted

Summary

This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Detailed description

Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	transplantation of hUC-MSCs	Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-07-01
• Completion: 2020-12-31
• First posted: 2019-03-13
• Last updated: 2019-03-14

Locations

1 site across 1 country: China