Stem Cells for Bronchopulmonary Dysplasia
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|ClinicalTrials.gov Identifier: NCT03378063|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia||Drug: transplantation of mesenchymal stem cell Drug: no transplantation of mesenchymal stem cell||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be given to the infants with BPD.
Drug: transplantation of mesenchymal stem cell
allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
Active Comparator: no transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be not given to the infants with BPD.
Drug: no transplantation of mesenchymal stem cell
MSC transplantation will be not given to preterm infants
- death [ Time Frame: within two years ]the infant is dead due to lung disease
- Bayley Scales of Infant Development [ Time Frame: 30 months after birth ]scores of Bayley Scales of Infant Development at 2 months old and 2 years old
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378063
|Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University||Recruiting|
|Chongqing, Chongqing, China, 400042|
|Contact: Long Chen, MD 8613883559467 firstname.lastname@example.org|
|Contact: Shi Yuan, PhD,MD|