Phase 2
Completed N=10
Perinatal Arterial Stroke Treated With Stromal Cells Intranasally
Perinatal Arterial Ischemic Stroke · Neonatal Stroke
Source: ClinicalTrials.gov NCT03356821 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Number of Participants With Adverse Events Related to Intranasal MSC Treatment (Safety and Tolerability) in the Acute Setting. — 10; 0; 9; 1 Participants
Summary
This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, administered by the nasal route, in neonates who suffered from PAIS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Related to Intranasal MSC Treatment (Safety and Tolerability) in the Acute Setting. |
10; 0; 9; 1 | — |
| SECONDARY Number of Participants With Adverse Events Related to Intranasal MSC Treatment (Safety and Tolerability) in the Subacute/Long-term Setting |
10; 0 | — |
Eligibility Criteria
Inclusion Criteria
- (Near-)Term infants, ≥36+0 weeks of gestation, admitted to one of the Dutch Neonatal Intensive Care Units, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms.
- PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery, 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.
Data sourced from ClinicalTrials.gov (NCT03356821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.