Clinical trial NCT05138276: Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
Official title: Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neonatal Necrotizing Enterocolitis
Growth and Development
Preterm Infants
Nutrition
Keywords: Necrotizing enterocolitis
Preterm infants
Prevention
cord blood mononuclear cells
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Study design and settings:

This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 45 singleton preterm infants (GS\<33 weeks) of fulfilling the eligibility criteria will be enrolled. According to the infusion of umbilical cord blood mononuclear cells and equal dose placebo, the premature infants were divided into infusion group and control group. The two groups were matched with gender, gestational age and birth weight as stratified variables and 1:2 (the gender was the same, and the difference between gestational age and birth weight was the smallest).

Trial treatment methods: Study design and settings:

This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.

Trial treatment methods:

Soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine treatment. Those assigned to the ACBMNC group received an infusion of ACBMNC . Those in control group received an infusion of a placebo solution. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through Guangdong Province umbilical cord blood Bank to obtain mesenchymal stem cells. Within 24h after birth, ACBMNC group received an infusion of mesenchymal stem cells timely, while control (placebo) group received an infusion of a placebo solution which is normal saline with the same volume. Cell dose for all patients was targeted at 5×107 cells per kilogram.

Eligibility criteria: 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.

Primary outcomes:
measure: The occurrence of Necrotizing enterocolitis in hospitalization
timeFrame: up to one year
Secondary outcomes:
measure: The severity of Necrotizing enterocolitis
timeFrame: up to one year
measure: The occurrence of feeding intolerance
timeFrame: up to one year
measure: The occurrence of other intestinal disease
timeFrame: up to one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Jie Yang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.