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Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).
This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous cord blood mononuclear cells | Experimental | Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Umbilical Cord Blood Mononuclear Cells Therapy | Other | Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home | bronchopulmonary dysplasia rate | 36 weeks of postmenstrual age or the discharge |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with severe BPD in survivors | severe BPD in survivors | 36 weeks of postmenstrual age or the discharge |
| number of patients died before discharge from hospital | mortality before discharge from hospital |
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Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.
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| Name | Affiliation | Role |
|---|---|---|
| Jie Yang, PHD | Guangdong Women and Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jie Yang | Guangzhou | Guangdong | 511442 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23673863 | Background | Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14. | |
| 26051681 | Background | Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2021 | |
| Unrelease | Nov 18, 2021 | |
| Release | Nov 18, 2021 | |
| Reset | Jan 27, 2022 | |
| Release | Jul 23, 2022 | |
| Unrelease | Aug 4, 2022 | |
| Release | Aug 7, 2024 | |
| Reset | Oct 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2021 | Nov 18, 2021 | |||
| Nov 18, 2021 |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| before discharge from hospital |
| the duration of mechanical ventilation | Other outcomes | before discharge from hospital |
| 22225756 | Background | Wannemuehler TJ, Manukyan MC, Brewster BD, Rouch J, Poynter JA, Wang Y, Meldrum DR. Advances in mesenchymal stem cell research in sepsis. J Surg Res. 2012 Mar;173(1):113-26. doi: 10.1016/j.jss.2011.09.053. Epub 2011 Oct 24. |
| Background | Leung, Kam Tong; Lam, Hugh Simon; Chan, Kathy Yuen Yee, Decreased Frequency of Circulating CD34+Hematopoietic Stem/Progenitor Cells in Preterm Infants with Late-Onset Systemic Bacterial Infection,Blood,2014.124.21 |
| 24046202 | Background | Lam HS, Cheung HM, Poon TC, Wong RP, Leung KT, Li K, Ng PC. Neutrophil CD64 for daily surveillance of systemic infection and necrotizing enterocolitis in preterm infants. Clin Chem. 2013 Dec;59(12):1753-60. doi: 10.1373/clinchem.2013.209536. Epub 2013 Sep 17. |
| 25913273 | Background | Ho MS, Mei SH, Stewart DJ. The Immunomodulatory and Therapeutic Effects of Mesenchymal Stromal Cells for Acute Lung Injury and Sepsis. J Cell Physiol. 2015 Nov;230(11):2606-17. doi: 10.1002/jcp.25028. |
| 23911205 | Background | van den Berg JP, van Zwieteren N, Westerbeek EA, Garssen J, van Elburg RM. Neonatal modulation of serum cytokine profiles by a specific mixture of anti-inflammatory neutral and acidic oligosaccharides in preterm infants. Cytokine. 2013 Oct;64(1):188-95. doi: 10.1016/j.cyto.2013.07.002. Epub 2013 Aug 2. |
| 19482760 | Background | Lam HS, Wong SP, Liu FY, Wong HL, Fok TF, Ng PC. Attitudes toward neonatal intensive care treatment of preterm infants with a high risk of developing long-term disabilities. Pediatrics. 2009 Jun;123(6):1501-8. doi: 10.1542/peds.2008-2061. |
| 24877996 | Background | Strunk T, Inder T, Wang X, Burgner D, Mallard C, Levy O. Infection-induced inflammation and cerebral injury in preterm infants. Lancet Infect Dis. 2014 Aug;14(8):751-762. doi: 10.1016/S1473-3099(14)70710-8. Epub 2014 May 28. |
| 37997800 | Derived | Ren Z, Yang L, Wang J, Han J, Lin S, Yao Y, Du C, Yang J. Cord blood stem cell-derived Angptl7 ameliorates the severity of bronchopulmonary dysplasia via anti-inflammatory and proangiogenic effects. Mol Med Rep. 2024 Jan;29(1):8. doi: 10.3892/mmr.2023.13131. Epub 2023 Nov 24. |
| 36864985 | Derived | Zhuxiao R, Fang X, Wei W, Shumei Y, Jianlan W, Qiuping L, Jingjun P, Chuan N, Yongsheng L, Zhichun F, Jie Y. Prevention for moderate or severe BPD with intravenous infusion of autologous cord blood mononuclear cells in very preterm infants-a prospective non-randomized placebo-controlled trial and two-year follow up outcomes. EClinicalMedicine. 2023 Feb 16;57:101844. doi: 10.1016/j.eclinm.2023.101844. eCollection 2023 Mar. |
| Jan 27, 2022 |
| Jul 23, 2022 | Aug 4, 2022 |
| Aug 7, 2024 | Oct 25, 2024 |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |