| Study name |
Neonatal hypoxic ischaemic encephalopathy: safety and feasibility study of a curative treatment with autologous cord blood stem cells (NEOSTEM) |
| Methods |
Phase 1, 2, open label study with single group assignment |
| Participants |
Sample size = 20
Inclusion criteria
Term ≥ 36 weeks of gestation and:
a blood pH < 7 with base deficit > 12 mmol/l (at birth or within 60 minutes of age); or a blood pH between 7.01 and 7.15, with additional criteria; a history of acute perinatal event (e.g. : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal haemorrhage); and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth; signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2); ± abnormal electroencephalogram or aEEG within 12 hours of age; therapeutic hypothermia; no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus; maternal negative serology for syphilis; written parental consent
|
| Interventions |
Autologous cord blood stem cell infusion |
| Outcomes |
Primary outcome: adverse clinical event rates due to stem cell preparation within 2 years of life |
| Starting date |
April 2017 |
| Contact information |
Study director: Catherine Geindre AP, HM |
| Notes |
Study sponsor: Assistance Publique Hopitaux De Marseille |
