Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
ACBMNC
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 25, 2022
April 1, 2022
1.3 years
May 21, 2021
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The occurrence of Necrotizing enterocolitis in hospitalization
NEC rate
up to one year
Secondary Outcomes (3)
The severity of Necrotizing enterocolitis
up to one year
The occurrence of feeding intolerance
up to one year
The occurrence of other intestinal disease
up to one year
Study Arms (2)
Autologous cord blood mononuclear cells
EXPERIMENTALAutologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Placebo
PLACEBO COMPARATOR0.9% sodium chloride infusion 24 hours after birth
Interventions
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jie Yang
Guangzhou, Guangdong, 511400, China
Related Publications (2)
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.
PMID: 23673863BACKGROUNDMezey 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.
PMID: 26051681BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Yang, PHD
Guangdong Women and Children Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Triple (Participant, Care Provider, Outcomes Assessor)
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 21, 2021
First Posted
November 30, 2021
Study Start
September 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share