Perinatal arterial Ischemic Stroke (PAIS)
Conditions
Interventions
Product Name: mesenchymale stem cells
Pharmaceutical Form: Nasal spray
Sponsors
University Medical Center Utrecht, The Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - (Near-)Term infants, =36+0 weeks of gestation, admitted to one of the Dutch NICUs, 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 - Written informed consent from custodial parent(s) Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will investigate whether bone marrow-derived allogeneic MSCs, as administered by the nasal route, can induce the formation of neuronal tissue and restore brain function in neonates who suffered from perinatal arterial ischemic stroke (PAIS) compared to a matched group of historic untreated controls. The ultimate goals of the present study is therefore to develop a therapy using adult human allogenic MSCs to reduce or even to prevent the lifelong consequences of PAIS-related brain damage in this group of term newborns. ;Secondary Objective: Not applicable;Primary end point(s): Our primary objective is to determine if MSC treatment reduces brain damage, which will be measured on one hand by the change in lesion size and brain growth between the time of onset of the insult and 3 months of age and on the other hand by change of reorganisation of the sensorimotor cortex after neonatal stroke. Change in lesion size and brain growth will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within 3 days after clinical presentation and at 3 months of age. We will use post-processing fibre-tracking programs on diffusion tension imaging (DTI) to detect whether MSC treatment stimulates reorganization of the sensorimotor cortex;Timepoint(s) of evaluation of this end point: at 3 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bayley scales (BSID-III scales: Mental development index (NDI) and psychomotor index (PDI) ;Timepoint(s) of evaluation of this end point: at 2-years of age | — |
Countries
Netherlands
Contacts
Public ContactHead of Department of Neonatology
University Medical Center Utrecht, The Netherlands
Outcome results
None listed