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Neonatal hypoxic ischemic encephalopathy : safety and feasibility study of a curative treatment with autologous cord blood stem cells (NEOSTEM)
EU CTIS ID: 2024-516421-30-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- signs of encephalopathy within 6 hours of age (Sarnat and Sarnat classification, score ≥ 2)
- - ± abnormal electroencephalogram or aEEG within 6 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
You likely can't join if
- major congenital anomalies, including severe metabolic diseases
- severe maternal-fetal infection responsible for anoxo-ischemia, with immediate
- head trauma responsible for intracranial hemorrhage
- severe IUGR (PN < 1800g)
- child whose death is foreseeable in the short term
- parental refusal
See the full eligibility criteria
- signs of encephalopathy within 6 hours of age (Sarnat and Sarnat classification, score ≥ 2)
- - ± abnormal electroencephalogram or aEEG within 6 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
- major congenital anomalies, including severe metabolic diseases
- severe maternal-fetal infection responsible for anoxo-ischemia, with immediate
- head trauma responsible for intracranial hemorrhage
- severe IUGR (PN < 1800g)
- child whose death is foreseeable in the short term
- parental refusal
- child born under X
- absence de recueil du sang de cordon.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.