Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)
Phase 2
Withdrawn
- Conditions
- Neonatal StrokePAIS1000796310028920
- Registration Number
- NL-OMON42174
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
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)
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>Our primary objective is to determine if MSC treatment reduces brain damage,<br /><br>which will be measured on one hand by the change in lesion size and brain<br /><br>growth between the time of onset of the insult and 3 months of age and on the<br /><br>other hand by change of reorganisation of the sensorimotor cortex after<br /><br>neonatal stroke. Change in lesion size and brain growth will be estimated using<br /><br>advanced volumetric magnetic resonance (MRI) techniques, performed within 3<br /><br>days after clinical presentation and at 3 months of age. We will use<br /><br>post-processing fibretracking<br /><br>programs on diffusion tension imaging (DTI) to detect whether MSC treatment<br /><br>stimulates reorganization of the sensorimotor cortex. These MRI-techniches are<br /><br>established within the Imaging Istituut (ISI) of the UMCU. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Long term outcome:<br /><br>All infants included in this study will be followed according to our<br /><br>standardized long term follow up studies which includes analysis of the<br /><br>BSID-III score (mental development index (MDI) and psychomotor development<br /><br>index (PDI)) at the corrected age of 24 months. The BSID-III offers a<br /><br>standardized assessment of cognitive and motor development for children aged 1<br /><br>month through 42 months. The MDI evaluates a variety of abilities:<br /><br>sensory/perceptual acuities, acquisition of object constancy, memory, learning,<br /><br>problem solving, vocalization, beginning of verbal communication, basis of<br /><br>abstract thinking. The gross motor classification system (GMFCS) will be used<br /><br>to assess the level of disabilty in those who do develop USCP and the Manual<br /><br>Abilty Classification System (MACS) will be used to assess hand involvement in<br /><br>more detail, but only at 4 years and beyond. </p><br>