Using cord blood stem cells to treat neonatal brain injury
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
This study is testing whether using a baby's own cord blood stem cells can help treat brain injuries caused by lack of oxygen at birth and improve their brain function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT02881970 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are term infants (≥ 36 weeks gestation) who exhibit signs of hypoxic-ischaemic encephalopathy shortly after birth.
Not a fit: Patients with known chromosomal anomalies or major congenital anomalies are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve neurological outcomes for infants suffering from neonatal hypoxic-ischaemic encephalopathy.
How similar studies have performed: While the use of cord blood stem cells is a promising area of research, this specific approach is still novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille
- Assistance Publique Hopitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Farid BOUBRED
- Email: farid.boubrd@ap-hm.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.