Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
1 other identifier
interventional
200
1 country
1
Brief Summary
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2017
Shorter than P25 for phase_1
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
February 10, 2017
CompletedStudy Start
First participant enrolled
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedApril 10, 2017
April 1, 2017
3 months
February 10, 2017
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients who died
mortality rate
up tp 21 days after birth
Secondary Outcomes (1)
number of patients with neurodevelopmental disorder assessed by Bayley Score
up to 1 month, 3 months, 6 months and 1 year
Study Arms (2)
Placebo1
PLACEBO COMPARATOR0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h，
CBMNC
EXPERIMENTALAutologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，
Interventions
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation
Eligibility Criteria
You may qualify if:
- Twenty-eight weeks to thirty-seven weeks
You may not qualify if:
- Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jie Yang
Guangzhou, Guangdong, 511442, 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: 23673863RESULTRen Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang QI, Yang J. Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]. Front Pediatr. 2020 Apr 2;8:136. doi: 10.3389/fped.2020.00136. eCollection 2020.
PMID: 32300579DERIVED
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
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- 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
February 10, 2017
First Posted
February 14, 2017
Study Start
February 10, 2017
Primary Completion
May 15, 2017
Study Completion
May 15, 2017
Last Updated
April 10, 2017
Record last verified: 2017-04