Perinatal Arterial Stroke Treated With Stromal Cells Intranasally (PASSIoN)
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|ClinicalTrials.gov Identifier: NCT03356821|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Arterial Ischemic Stroke Neonatal Stroke||Biological: Mesenchymal Stem Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A phase I/II, open-label, single-arm, single-center intervention study in the NICU at the Wilhelmina children's Hospital / University Medical Centre in Utrecht of (near-)term newborns ≥36 weeks of gestation within the first week of onset of presenting clinical symptoms.|
|Masking:||None (Open Label)|
|Official Title:||Adult Mesenchymal Stromal Cells to Regenerate the Neonatal Brain: the PASSIoN Trial (Perinatal Arterial Stroke Treated With Stromal Cells IntraNasally)|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Mesenchymal Stem Cells
All (near-)term newborns ≥36 weeks of gestation with or without clinical symptoms of PAIS but with a magnetic resonance imaging (MRI) confirmed PAIS (in the Middle Cerebral Artery region) will be eligible for this study. Following written parental consent, 10 patients will be included in our study.
Biological: Mesenchymal Stem Cells
One dose of 50x10^6 bone marrow-derived allogeneic MSCs via the nasal route as soon as possible after confirmation of the stroke (in the middle cerebral artery), but within the first week of onset of presenting clinical symptoms. Within 30 minutes after cleaning the nose with saline, using standard procedures operative at the Neonatal Intensive Care Unit, the MSC will be delivered.
Other Name: Bone Marrow-derived Allogeneic Mesenchymal Cells
- Incidence of adverse events related to intranasal MSC treatment (safety and tolerability) in the acute setting. [ Time Frame: 24 hours after treatment ]The primary objective is to determine if MSC treatment in neonates with PAIS is safe and tolerable in the acute setting. This will be measured by the incidence of treatment-related adverse events after MSC treatment.
- Incidence of adverse events related to intranasal MSC treatment (safety and tolerability) in the subacute/long-term setting [ Time Frame: 3 months postnatal age ]The secondary objective is to determine subacute and long-term safety of MSC treatment at 3 months. This will be measured by the occurence of treatment-related adverse events, such as infections or cerebral tumorigenicity on MRI. Follow-up assessment at 3 months is part of regular care for neonates with PAIS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356821
|Contact: Linda S. de Vries, MD, PhD||+31(0)email@example.com|
|Contact: Nienke Wagenaar, MD||+31(0)887554545 ext firstname.lastname@example.org|
|Wilhelmina Childrens Hostpital/University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 EA|
|Principal Investigator:||Linda S. de Vries, MD, PhD||UMC Utrecht|
|Principal Investigator:||Manon Benders, MD, PhD||UMC Utrecht|
|Principal Investigator:||Floris Groenendaal, MD, PhD||UMC Utrecht|
|Principal Investigator:||Frank van Bel, MD, PhD||UMC Utrecht|