NCT02881970 Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
| NCT ID | NCT02881970 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Neonatal Hypoxic-ischaemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-02-05 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2020-02-05 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy. The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration
Eligibility Criteria
Inclusion Criteria: Term ≥ 36 weeks of gestation * and (2) : * 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 additionnal criteria: * a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage) * 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 Exclusion Criteria: * presence of known chromosomal anomaly. * presence of major congenital anomalies. severe intrauterine growth restriction (weight \<1800g) * infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
Contact & Investigator
Farid BOUBRED
✉ farid.boubrd@ap-hm.frCATHERINE GEINDRE
STUDY DIRECTOR
AP HM
Frequently Asked Questions
Who can join the NCT02881970 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 3 Days, studying Neonatal Hypoxic-ischaemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02881970 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02881970 currently recruiting?
Yes, NCT02881970 is actively recruiting participants. Contact the research team at farid.boubrd@ap-hm.fr for enrollment information.
Where is the NCT02881970 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT02881970 clinical trial?
NCT02881970 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is CATHERINE GEINDRE at AP HM. The trial plans to enroll 20 participants.