Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)

Phase 2

Completed

Conditions: Neonatal Stroke
PAIS
10007963
10028920

Registration Number: NL-OMON50715

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* (Near-)Term infants, *36+0 weeks of gestation, admitted to one of the Dutch
NICUs, diagnosed with PAIS, confirmed by MRI within 7 days after presentation
with clinical symptoms.
* PAIS as characterized by a predominantly unilateral ischemic lesion within
the territory of the MCA, with involvement of the corticospinal tracts, cortex,
white matter and basal ganglia.
* Written informed consent from custodial parent(s).

Exclusion Criteria

- Any proven or suspected congenital anomaly, chromosomal disorder, metabolic
disorder.
- Presence of an infection of the central nervous system.
- No realistic prospect of survival, (e.g. severe brain injury), at the
discretion of the attending physician.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective is to determine if MSC treatment in (near-)term infants with<br /><br>PAIS is safe. Safety is defined primarily as the absence of treatment-related<br /><br>serious adverse events (SAEs) according to the Consolidated Standards of<br /><br>Reporting Trials, secondly as the absence of dose-limiting toxicity, defined as<br /><br>death within 24 hours after MSC transplantation or anaphylactic shock related<br /><br>to the MSC administration. At least, all patients will be regularly and<br /><br>intensively assessed, including blood sampling and vital signs, before and 24<br /><br>hours after treatment, until discharge from our hospital. </p><br>

Secondary Outcome Measures