Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873506
• Other study ID #: yunqiu xia
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Children's Hospital of Chongqing Medical University
• Contact: Yunqiu Xia
• Phone: 13637719980
• Email: sunny_199001[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

1. Subject who completed the safety and efficacy evaluations in hUC-MSCs Phase? clinical trial

2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

1. Subject whose parent or legal representative does not agree to participate in the study

2. subject who is considered inappropriate to participate the study by the investigator

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Drug:
• transplantation of hUC-MSCs
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21. — View Citation

Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission rate		within two years
Primary	Duration of the hospital stay due to respiratory infection		within two years
Secondary	Rate of Survival		within two years
Secondary	Incidence of Tumorigenicity		within two years
Secondary	Growth measured by Z-score		within two years
Secondary	Number of neurological developmental delay		within two years
Secondary	Number of blindness and deafness		within two years