Clinical trial • Phase II • Neurology

Autologous cord blood-derived mononuclear cells for Hypoxic-ischemic encephalopathy (neonatal)

Phase II trial of Autologous cord blood-derived mononuclear cells for Hypoxic-ischemic encephalopathy (neonatal). 20 participants.

Overview

Phase II trial across 12 sites in France.

Recruits 20 paediatric patients.

Vulnerable Population: Neonates are the vulnerable population. Consent is required from parents: "written parental consent" is listed as an inclusion criterion and subject information / informed consent forms are provided for the study.

{"criterion_text":"- signs of encephalopathy within 6 hours of age (Sarnat and Sarnat classification, score ≥ 2)"}
{"criterion_text":"-\t± abnormal electroencephalogram or aEEG within 6 hours of age"}
{"criterion_text":"-\ttherapeutic hypothermia."}
{"criterion_text":"-\tno maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus"}
{"criterion_text":"- maternal negative serology for syphilis"}
{"criterion_text":"- written parental consent"}

{"criterion_text":"- major congenital anomalies, including severe metabolic diseases"}
{"criterion_text":"- severe maternal-fetal infection responsible for anoxo-ischemia, with immediate"}
{"criterion_text":"- head trauma responsible for intracranial hemorrhage"}
{"criterion_text":"- severe IUGR (PN < 1800g)"}
{"criterion_text":"- child whose death is foreseeable in the short term"}
{"criterion_text":"- parental refusal"}
{"criterion_text":"- child born under X"}
{"criterion_text":"- absence de recueil du sang de cordon."}

{"endpoint_text":"- Occurrence of clinical or paraclinical adverse events during the child's follow-up (short- and long-term), attributable to the injected cell preparation","definition_or_measurement_approach":"Monitoring and recording of clinical or paraclinical adverse events during the child's follow-up (short- and long-term), assessed as attributable to the injected cell preparation."}
{"endpoint_text":"- Feasibility of the study: percentage of children included for whom the cell therapy procedure could be completed according to the required quality criteria.","definition_or_measurement_approach":"Calculated as the percentage of included children for whom the cell therapy procedure could be completed according to the required quality criteria."}

{"endpoint_text":"-\tPreliminary efficacy as measured by neurodevelopmental function till 2 years","definition_or_measurement_approach":"Assessment of neurodevelopmental function up to 2 years of age as a measure of preliminary efficacy."}

Planned Sample Size: 20
Recruitment Window Months: 96
Consent Approach: Written parental consent is required ("written parental consent" is listed in inclusion criteria). Subject information and informed consent forms are included in the study documents.

Site Name: Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name: medecine neonatale
Contact Person Name: yves RIMET
Contact Person Email: yves.rimet@ch-aix.fr

Investigational Product Name: Autologous cord blood-derived viable nuclear cells 50E6/kg prep
Active Substance: Autologous cord blood-derived mononuclear cells
Modality: Cell therapy
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS
Maximum Dose: 100000000 CFU/g colony forming unit(s)/gram

Other published trials that may interest you.