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Neonatal hypoxic ischemic encephalopathy : safety and feasibility study of a curative treatment with autologous cord blood stem cells (NEOSTEM)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516421-30-00
Enrollment
20
Registered
2024-09-10
Start date
2020-02-05
Completion date
Unknown
Last updated
2024-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal hypoxic-ischaemic encephalopathy

Brief summary

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

Detailed description

- Preliminary efficacy as measured by neurodevelopmental function till 2 years

Interventions

DRUGAutologous cord blood-derived viable nuclear cells 50E6/kg prep

Sponsors

Centre Hospitalier Regional De Marseille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Occurrence of clinical or paraclinical adverse events during the child's follow-up (short- and long-term), attributable to the injected cell preparation, Feasibility of the study: percentage of children included for whom the cell therapy procedure could be completed according to the required quality criteria.

Secondary

MeasureTime frame
- Preliminary efficacy as measured by neurodevelopmental function till 2 years

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026