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

Primary Purpose

Neonatal Necrotizing Enterocolitis, Growth and Development, Preterm Infants

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
0.9% Sodium Chloride
Sponsored by
Guangdong Women and Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Necrotizing Enterocolitis focused on measuring Necrotizing enterocolitis, Preterm infants, Prevention, cord blood mononuclear cells

Eligibility Criteria

26 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jie YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous cord blood mononuclear cells

Placebo

Arm Description

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

0.9% sodium chloride infusion 24 hours after birth

Outcomes

Primary Outcome Measures

The occurrence of Necrotizing enterocolitis in hospitalization
NEC rate

Secondary Outcome Measures

The severity of Necrotizing enterocolitis
severe NEC
The occurrence of feeding intolerance
Other outcomes
The occurrence of other intestinal disease
Other outcomes

Full Information

First Posted
May 21, 2021
Last Updated
April 22, 2022
Sponsor
Guangdong Women and Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05138276
Brief Title
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
Acronym
ACBMNC
Official Title
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Women and Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Necrotizing Enterocolitis, Growth and Development, Preterm Infants, Nutrition
Keywords
Necrotizing enterocolitis, Preterm infants, Prevention, cord blood mononuclear cells

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous cord blood mononuclear cells
Arm Type
Experimental
Arm Description
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride infusion 24 hours after birth
Intervention Type
Other
Intervention Name(s)
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Intervention Description
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
0.9% Sodium Chloride in control group
Primary Outcome Measure Information:
Title
The occurrence of Necrotizing enterocolitis in hospitalization
Description
NEC rate
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
The severity of Necrotizing enterocolitis
Description
severe NEC
Time Frame
up to one year
Title
The occurrence of feeding intolerance
Description
Other outcomes
Time Frame
up to one year
Title
The occurrence of other intestinal disease
Description
Other outcomes
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayu Miao, MD
Phone
13560324100
Email
sara930924@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Yang, PHD
Organizational Affiliation
Guangdong Women and Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jie Yang
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yang, PHD
Phone
39151777
Ext
020
Email
jasjie_yang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23673863
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.
Results Reference
background
PubMed Identifier
26051681
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.
Results Reference
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Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

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