Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)

Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally) - Stromal cells and the neonatal brain: PASSIoN-trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50715

Enrollment

Registered

2016-10-19

Start date

2020-02-10

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Stroke

Interventions

Based on preclinical data already obtained we anticipate the following ranges for the treatment protocol: the infants will be treated with one dose of 50 million MSCs via the nasal route within with

Eligibility

Age

2 Years to 11 Years

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 7 days after presentation with clinical symptoms. * PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the MCA, with involvement of the corticospinal tracts, cortex, white matter and basal ganglia. * Written informed consent from custodial parent(s).

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
Primary objective is to determine if MSC treatment in (near-)term infants with PAIS is safe. Safety is defined primarily as the absence of treatment-related serious adverse events (SAEs) according to the Consolidated Standards of Reporting Trials, secondly as the absence of dose-limiting toxicity, defined as death within 24 hours after MSC transplantation or anaphylactic shock related to the MSC administration. At least, all patients will be regularly and intensively assessed, including blood sampling and vital signs, before and 24 hours after treatment, until discharge from our hospital.	—

Measure

Time frame

Primary objective is to determine if MSC treatment in (near-)term infants with PAIS is safe. Safety is defined primarily as the absence of treatment-related serious adverse events (SAEs) according to the Consolidated Standards of Reporting Trials, secondly as the absence of dose-limiting toxicity, defined as death within 24 hours after MSC transplantation or anaphylactic shock related to the MSC administration. At least, all patients will be regularly and intensively assessed, including blood sampling and vital signs, before and 24 hours after treatment, until discharge from our hospital.

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Secondary

Measure	Time frame
Our secundary objective is to determine if MSC treatment in (near-)term infants with PAIS is safe at the subacute and 'long-term' setting: * To determine if MSC treatment in (near-)term infants with PAIS is safe in the subacute setting. Subacute safety is defined primarily as the absence of treatment-related serious adverse events (SAEs) according to the Consolidated Standards of Reporting Trials (chapter 7.2) until the age of 3 months. Patients will then be asked to report on other SAEs, including infections. * To determine if MSC treatment in (near-)term infants with PAIS is safe at 3 months in terms of cerebral tumorigenicity. To assess safety of MSC treatment on the brain, infants will be scanned using MRI prior to MSC treatment and at 3 months of age. Long-term adverse effects on the brain in terms of tumorigenicity will be determined using this MRI, which is part of regular stroke follow-up program.	—

Measure

Time frame

Our secundary objective is to determine if MSC treatment in (near-)term infants with PAIS is safe at the subacute and 'long-term' setting: * To determine if MSC treatment in (near-)term infants with PAIS is safe in the subacute setting. Subacute safety is defined primarily as the absence of treatment-related serious adverse events (SAEs) according to the Consolidated Standards of Reporting Trials (chapter 7.2) until the age of 3 months. Patients will then be asked to report on other SAEs, including infections. * To determine if MSC treatment in (near-)term infants with PAIS is safe at 3 months in terms of cerebral tumorigenicity. To assess safety of MSC treatment on the brain, infants will be scanned using MRI prior to MSC treatment and at 3 months of age. Long-term adverse effects on the brain in terms of tumorigenicity will be determined using this MRI, which is part of regular stroke follow-up program.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)