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This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants for moderate and severe Bronchopulmonary Dysplasia(BPD).
BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.
hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe BPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplantation of Mesenchymal Stem Cell | Experimental | Mesenchymal stem cell will be given to preterm infants with BPD. |
|
| No Transplantation of Mesenchymal Stem Cell | Active Comparator | Mesenchymal stem cell will be not given to preterm infants with BPD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of mesenchymal stem cell | Drug | Human umbilical cord-derived mesenchymal stem cell will be given to preterm infants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse reactions related to infusion after treatment | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. | 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of high-resolution chest CT in participants | To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD. | within 2 years after administration |
| Changes of temperature in participants |
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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 | 400014 | 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. | |
| 21336467 | Background | Hayes D Jr, Meadows JT Jr, Murphy BS, Feola DJ, Shook LA, Ballard HO. Pulmonary function outcomes in bronchopulmonary dysplasia through childhood and into adulthood: implications for primary care. Prim Care Respir J. 2011 Jun;20(2):128-33. doi: 10.4104/pcrj.2011.00002. |
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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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|
| No transplantation of mesenchymal stem cell | Drug | Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion. |
|
|
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
| 3 days after administration |
| Changes of blood pressure in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer . | 3 days after administration |
| Changes of heart rate in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. | 3 days after administration |
| Changes of respiratory rate in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. | 3 days after administration |
| Changes of oxygen saturation in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. | 3 days after administration |
| Growth velocity (Z-score) in participants | To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD. | within 2 years after administration |
| 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. |
| 25529339 | Background | Wilson JG, Liu KD, Zhuo H, Caballero L, McMillan M, Fang X, Cosgrove K, Vojnik R, Calfee CS, Lee JW, Rogers AJ, Levitt J, Wiener-Kronish J, Bajwa EK, Leavitt A, McKenna D, Thompson BT, Matthay MA. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. Lancet Respir Med. 2015 Jan;3(1):24-32. doi: 10.1016/S2213-2600(14)70291-7. Epub 2014 Dec 17. |
| 26928452 | Background | Laube M, Stolzing A, Thome UH, Fabian C. Therapeutic potential of mesenchymal stem cells for pulmonary complications associated with preterm birth. Int J Biochem Cell Biol. 2016 May;74:18-32. doi: 10.1016/j.biocel.2016.02.023. Epub 2016 Feb 27. |
| 23212278 | Background | Pierro M, Ionescu L, Montemurro T, Vadivel A, Weissmann G, Oudit G, Emery D, Bodiga S, Eaton F, Peault B, Mosca F, Lazzari L, Thebaud B. Short-term, long-term and paracrine effect of human umbilical cord-derived stem cells in lung injury prevention and repair in experimental bronchopulmonary dysplasia. Thorax. 2013 May;68(5):475-84. doi: 10.1136/thoraxjnl-2012-202323. Epub 2012 Dec 4. |
| 22837858 | Background | Hansmann G, Fernandez-Gonzalez A, Aslam M, Vitali SH, Martin T, Mitsialis SA, Kourembanas S. Mesenchymal stem cell-mediated reversal of bronchopulmonary dysplasia and associated pulmonary hypertension. Pulm Circ. 2012 Apr-Jun;2(2):170-81. doi: 10.4103/2045-8932.97603. |
| 37223507 | Derived | Xia Y, Lang T, Niu Y, Wu X, Zhou O, Dai J, Bao L, Yang K, Zou L, Fu Z, Geng G. Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia. Genes Dis. 2022 Feb 22;10(2):521-530. doi: 10.1016/j.gendis.2022.02.001. eCollection 2023 Mar. |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |