Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

Study Overview
=================
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.

Official Title
-----------------
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

Conditions
-----------------
Neonatal Necrotizing Enterocolitis, Growth and Development, Preterm Infants, Nutrition

Intervention / Treatment
-----------------
* Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
* Drug: 0.9% Sodium Chloride


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous cord blood mononuclear cells<br>Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg | Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy<br>* Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC<br>|
| Placebo Comparator: Placebo<br>0.9% sodium chloride infusion 24 hours after birth | Drug: 0.9% Sodium Chloride<br>* 0.9% Sodium Chloride in control group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of Necrotizing enterocolitis in hospitalization | NEC rate | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of Necrotizing enterocolitis | severe NEC | up to one year | 
| The occurrence of feeding intolerance | Other outcomes | up to one year | 
| The occurrence of other intestinal disease | Other outcomes | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Necrotizing enterocolitis, Preterm infants, Prevention, cord blood mononuclear cells