Using cord blood stem cells to treat neonatal brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and feasibility of using autologous cord blood stem cells as a treatment for neonatal hypoxic-ischaemic encephalopathy, a serious condition caused by brain asphyxia. The primary goal is to assess whether this innovative approach can restore neuronal functions and prevent neurological damage in affected infants. The study will also evaluate the optimal timing for administering the stem cells to maximize their efficacy. Participants will be closely monitored for any adverse effects and improvements in neurological outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Assistance Publique Hopitaux de Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Farid BOUBRED
• Email: farid.boubrd@ap-hm.fr

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.