NCT03352310

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mononuclear Therapeutics Ltd. · Industry
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

Summary

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group. Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Hypoxia Neonatal
• Cerebral Ischemia of Newborn
• Anemia, Neonatal

Interventions

Type	Name	Description
BIOLOGICAL	autologous umbilical cord blood (UCB)	autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
PROCEDURE	standard care	standard care procedure to the newborn infants presence of HIE and/or anemia

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-06-30
• Completion: 2020-12-30
• First posted: 2017-11-24
• Last updated: 2018-06-07

Locations

1 site across 1 country: Hong Kong