Table 1.
Clinical trials being conducted around the world using umbilical cord blood in regenerative medicine therapies for the management of cerebral palsy and ischemic brain injury in the newborn.
| Study title | Main objective | Institution | Treatment | Current status | Trial identifier |
|---|---|---|---|---|---|
| A randomized study of autologous umbilical cord blood reinfusion in children with cerebral palsy | To determine the efficacy of a single intravenous infusion of autologous umbilical cord blood for the treatment of pediatric patients with spastic cerebral palsy. | Duke University, United States | Intravenous infusion. Autologous umbilical cord blood. | Currently recruiting | NCT01147653 |
| Timing: not specified. (children 12 months–6 years of age enrolled). | |||||
| Characterization of the cord blood stem cell in situation of neonatal asphyxia (NEOCORD) | To characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. | Assistance publique Hopitaux de Marseille | In vitro characterization of the cord blood stem cell only. | Currently recruiting | NCT01284673 |
| Allogenic umbilical cord blood and erythropoietin combination therapy for cerebral palsy | To determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy. | Sung Kwang Medical Foundation, Korea | Intravenous allogeneic umbilical cord blood infusion (total nucleated cells >3 × 10∧7/kg) in combination with erythropoietin given twice a week for 4 weeks. | Completed | NCT01193660 |
| Timing: up to 6 months after adverse event. | |||||
| Safety and effectiveness of cord blood stem cell infusion for the treatment of cerebral palsy in children | To test the safety and effectiveness of a cord blood infusion in children who have motor disability due to cerebral palsy. The subjects will be children whose parents have saved their infant's cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion. | Georgia Health Sciences University, United States | Intravenous infusion of red-cell depleted, mononuclear cell enriched cord blood. | Currently recruiting | NCT01072370 |
| Timing: not specified. (children 1–12 years of age enrolled). | |||||
| Autologous stem cells in newborns with oxygen deprivation | To determine if the plasticity of autologous intravenous administration of cord blood stem cells would improve the clinical course of asphyxiated newborns. | Hospital Universitario, Monterrey, Mexico | Intravenous infusion of autologous cord and placental cord blood (CD34+ Cells). | Currently recruiting | NCT01506258 |
| Timing: within the first 48 h after birth. | |||||
| Umbilical cord blood therapy for cerebral palsy | To evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy. | Bundang CHA Hospital, Republic of Korea | Umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression. | Completed | NCT01528436 |
| Timing: not specified. (children 6 months–20 years of age enrolled). | |||||
| Umbilical cord blood therapy for children with cerebral palsy | To evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy. | Bundang CHA Hospital, Republic of Korea | Allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression. | Ongoing, but NOT recruiting | NCT01639404 |
| Timing: not specified. (children 6 months–20 years of age enrolled). | |||||
| Autologous umbilical cord blood transfusion for preterm neonates | To test feasibility of collection, preparation and infusion of autologous umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation. | Ain Shams University, Cairo, Egypt | Autologous intravenous cord blood transfusion. | Currently recruiting | NCT01121328 |
| Timing: within the first 14 postnatal day. | |||||
| Autologous cord blood cells for brain injury in term newborns | To test feasibility and safety of collection, preparation and infusion of autologous umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. | National University Hospital, Singapore | Intravenous infusion of autologous cord blood. | Currently recruiting | NCT01649648 |
| Timing: 3 days post-birth. | |||||
| Cord blood for neonatal hypoxic-ischemic encephalopathy | To test feasibility of collection, preparation and infusion of a baby's own umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury. | Duke University, United States | Intravenous infusions autologous volume reduced cord blood cells (up to 4 infusions). | Currently recruiting | NCT00593242 |
| Timing: first 18 postnatal days. |
Information obtained from ClinicalTrials.gov. September 2013.