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Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates

Primary Purpose

Safety Issues, Effect of Drugs, Neonatal Death

Status
Unknown status
Phase
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 Safety Issues focused on measuring cord blood mononuclear cells, safety, effect, neonates

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Twenty-eight weeks to thirty-seven weeks

Exclusion Criteria:

  • Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Sites / Locations

  • Jie YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo1

CBMNC

Arm Description

0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h, 8-12h,

Autologous 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,

Outcomes

Primary Outcome Measures

number of patients who died
mortality rate

Secondary Outcome Measures

number of patients with neurodevelopmental disorder assessed by Bayley Score
Long term follow up: in 1 month, 3 months, 6 months, and 1 year: neuro-development

Full Information

First Posted
February 10, 2017
Last Updated
April 7, 2017
Sponsor
Guangdong Women and Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03053076
Brief Title
Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
Official Title
Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
May 15, 2017 (Anticipated)
Study Completion Date
May 15, 2017 (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
Yes

5. Study Description

Brief Summary
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
Detailed Description
This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period. Demographic Data and Baseline Characteristics of the Studied Groups were collected: Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP before intervention (mg/L) TNF-α(tumor necrosis factor α ) before intervention (pg/mL) Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously Autologous cord blood mononuclear cells doses is 25 million cells/kg ,the infusion speed is 4ml/kg/h, 8-12h,and with same volume of 0.9% sodium chloride as placebo. The following are monitored at 3、7、14、21 days after birth: mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge. Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Effect of Drugs, Neonatal Death
Keywords
cord blood mononuclear cells, safety, effect, neonates

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo1
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h, 8-12h,
Arm Title
CBMNC
Arm Type
Experimental
Arm Description
Autologous 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,
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 safety and effect evaluation
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
0.9% Sodium Chloride in control group
Primary Outcome Measure Information:
Title
number of patients who died
Description
mortality rate
Time Frame
up tp 21 days after birth
Secondary Outcome Measure Information:
Title
number of patients with neurodevelopmental disorder assessed by Bayley Score
Description
Long term follow up: in 1 month, 3 months, 6 months, and 1 year: neuro-development
Time Frame
up to 1 month, 3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Twenty-eight weeks to thirty-seven weeks Exclusion Criteria: Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhuxiao Ren, MD
Phone
+8613538984634
Ext
+86
Email
renzhx1990@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
511442
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
Undecided
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
result
PubMed Identifier
32300579
Citation
Ren 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.
Results Reference
derived

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Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates

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