Safety of Autologous Cord Blood Cells for Preterm Infants.

Early Phase 1

Completed

• Conditions: Safety Issues; Effect of Drugs; Neonatal Death
• Interventions: Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy

• Registration Number: NCT03760900
• Lead Sponsor: Guangdong Women and Children Hospital

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.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2010-01-01
• Study Completion: 2016-06-05
• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infusion group	Autologous Umbilical Cord Blood Stem Cells Therapy	Autologous Umbilical Cord Blood Stem Cells Therapy

Primary Outcome Measures

Name	Time	Method
Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants	2years	1. The growth and development curve will be drawn and compared
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants	6 hours after infusion	1. vital signs; 2. blood gas analysis; 3. blood routine; 4. liver and kidney function before and after infusion will be compared