Safety of Autologous Cord Blood Cells for Preterm Infants.
Primary Purpose
Safety Issues, Effect of Drugs, Neonatal Death
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Autologous Umbilical Cord Blood Stem Cells Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Safety Issues focused on measuring Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
Eligibility Criteria
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
infusion group
Arm Description
Autologous Umbilical Cord Blood Stem Cells Therapy
Outcomes
Primary Outcome Measures
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
1. The growth and development curve will be drawn and compared
Secondary Outcome Measures
Full Information
NCT ID
NCT03760900
First Posted
November 23, 2018
Last Updated
May 29, 2020
Sponsor
Guangdong Women and Children Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03760900
Brief Title
Safety of Autologous Cord Blood Cells for Preterm Infants.
Official Title
Safety of Autologous Cord Blood Cells for Preterm Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
January 1, 2010 (Actual)
Study Completion Date
June 5, 2016 (Actual)
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 assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Detailed Description
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).
Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.
Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively.
Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
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
Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
infusion group
Arm Type
Experimental
Arm Description
Autologous Umbilical Cord Blood Stem Cells Therapy
Intervention Type
Combination Product
Intervention Name(s)
Autologous Umbilical Cord Blood Stem Cells Therapy
Intervention Description
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth
Primary Outcome Measure Information:
Title
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
Description
vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
Time Frame
during infusion
Title
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
Description
vital signs
blood gas analysis
blood routine
liver and kidney function before and after infusion will be compared
Time Frame
6 hours after infusion
Title
Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
Description
1. The growth and development curve will be drawn and compared
Time Frame
2years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jie Yang, PHD
Organizational Affiliation
Guangdong Women and Children Hospital and Healthy Institutes
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety of Autologous Cord Blood Cells for Preterm Infants.
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