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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Necrotizing Enterocolitis Growth and Development Preterm Infants Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Triple (Participant, Care Provider, Outcomes Assessor)

Study Groups

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Autologous cord blood mononuclear cells

Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg

Group Type EXPERIMENTAL

Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Intervention Type OTHER

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC

Placebo

0.9% sodium chloride infusion 24 hours after birth

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type DRUG

0.9% Sodium Chloride in control group

Interventions

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Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC

Intervention Type OTHER

0.9% Sodium Chloride

0.9% Sodium Chloride in control group

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No