Nutrition Clinical Trial
— ACBMNCOfficial title:
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
Pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease. This single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing NEC in preterm neonates,and influence on growth and development.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 26 Weeks to 32 Weeks |
Eligibility | Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) 26<GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; Exclusion criteria: (1) mothers with clinical chorioamnionitis; (2) the mother was opsitive 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; (3) consent was not obtained from the parents or guardians; and (4) after processing, UCB cells were not available. |
Country | Name | City | State |
---|---|---|---|
China | Jie Yang | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Women and Children Hospital |
China,
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
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The occurrence of Necrotizing enterocolitis in hospitalization | NEC rate | up to one year | |
Secondary | The severity of Necrotizing enterocolitis | severe NEC | up to one year | |
Secondary | The occurrence of feeding intolerance | Other outcomes | up to one year | |
Secondary | The occurrence of other intestinal disease | Other outcomes | up to one year |
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