Status:
COMPLETED
Perinatal Arterial Stroke Treated With Stromal Cells Intranasally
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
M.D. Anderson Cancer Center
Conditions:
Perinatal Arterial Ischemic Stroke
Neonatal Stroke
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Perinatal arterial ischemic stroke (PAIS) is an important perinatal cause of long-lasting neurodevelopmental problems. Recent studies report an incidence of PAIS of 1 per 2300 full-term infants born a...
Eligibility Criteria
Inclusion
- (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
- 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.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03356821
Start Date
February 11 2020
End Date
July 27 2021
Last Update
May 13 2024
Active Locations (1)
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1
Wilhelmina Childrens Hostpital/University Medical Center Utrecht
Utrecht, Netherlands, 3584 EA