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Stem Cells for Bronchopulmonary Dysplasia

Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03378063
Enrollment
0
Registered
2017-12-19
Start date
2017-11-01
Completion date
2022-12-30
Last updated
2023-05-01

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

Conditions

Bronchopulmonary Dysplasia

Brief 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

Detailed 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.

Interventions

allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants

MSC transplantation will be not given to preterm infants

Sponsors

Children's Hospital of Chongqing Medical University
CollaboratorOTHER
Chongqing Maternal and Child Health Hospital
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
No

Inclusion criteria

* diagnosed with BPD

Exclusion criteria

* parents' rejection

Design outcomes

Primary

MeasureTime frameDescription
deathwithin two yearsthe infant is dead due to lung disease

Secondary

MeasureTime frameDescription
Bayley Scales of Infant Development30 months after birthscores of Bayley Scales of Infant Development at 2 months old and 2 years old

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026