Safety of Autologous Cord Blood Cells for Preterm Infants.

Safety Issues Clinical Trial

Official title:

Safety of Autologous Cord Blood Cells for Preterm Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760900
• Other study ID #: Guang dong WCH
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2009
• Est. completion date: June 5, 2016

Study information

• Verified date: May 2020
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 5, 2016
• Est. primary completion date: January 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Drugs
• Neonatal Death
• Perinatal Death
• Safety Issues

Intervention

Combination Product:
• Autologous Umbilical Cord Blood Stem Cells Therapy
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during infusion
Primary	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	6 hours after infusion
Primary	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	2years