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NCT02999373 Clinical Trial

Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

Bronchopulmonary Dysplasia Clinical Trial

Official title:
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02999373
Other study ID # Guangdong M And C
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date January 1, 2020

Study information
Verified date October 2021
Source Guangdong Women and Children Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 32 Weeks
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection

Locations
Country Name City State
China Jie Yang Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Mezey É, 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home bronchopulmonary dysplasia rate 36 weeks of postmenstrual age or the discharge
Secondary number of patients with severe BPD in survivors severe BPD in survivors 36 weeks of postmenstrual age or the discharge
Secondary number of patients died before discharge from hospital mortality before discharge from hospital before discharge from hospital
Secondary the duration of mechanical ventilation Other outcomes before discharge from hospital
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