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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 Phaseâ… trial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.
Subjects who completed the initial stage of the Phaseâ… clinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cell | Experimental | A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transplantation of hUC-MSCs | Drug | Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readmission rate | within two years | |
| Duration of the hospital stay due to respiratory infection | within two years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Survival | within two years | |
| Incidence of Tumorigenicity | within two years | |
| Growth measured by Z-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunqiu Xia | Contact | 13637719980 | sunny_199001@foxmail.com | |
| Lin Zou | Contact | 18623121280 |
| Name | Affiliation | Role |
|---|---|---|
| Zhou Fu | Children's Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24508444 | Background | 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. | |
| 28341525 | Background | 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. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| within two years |
| Number of neurological developmental delay | within two years |
| Number of blindness and deafness | within two years |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |