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NCT03378063 Clinical Trial

Stem Cells for Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:
Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03378063
Other study ID # stem cell for BPD
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date November 1, 2017
Est. completion date December 30, 2022

Study information
Verified date February 2021
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants

Description:

Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types. transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Months
Eligibility Inclusion Criteria: - diagnosed with BPD Exclusion Criteria: - parents' rejection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• transplantation of mesenchymal stem cell
allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
• no transplantation of mesenchymal stem cell
MSC transplantation will be not given to preterm infants

Locations
Country Name City State
China Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University Chongqing Chongqing

Sponsors (3)
Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary death the infant is dead due to lung disease within two years
Secondary Bayley Scales of Infant Development scores of Bayley Scales of Infant Development at 2 months old and 2 years old 30 months after birth
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