CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Mesenchymal Stem Cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03356821
NCT03356821Phase 2Completed
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Adult Mesenchymal Stromal Cells to Regenerate the Neonatal Brain: the PASSIoN Trial (Perinatal Arterial Stroke Treated With Stromal Cells IntraNasally)

UMC Utrecht·interventional·Posted Nov 29, 2017·Updated May 13, 2024

In Brief

A Phase 2 clinical trial evaluating Mesenchymal Stem Cells for Perinatal Arterial Ischemic Stroke and Neonatal Stroke. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerinatal Arterial Ischemic Stroke, Neonatal Stroke
CountriesNetherlands
CollaboratorsZonMw: The Netherlands Organisation for Health Research and Development, M.D. Anderson Cancer Center, The University of Texas Health Science Center at San Antonio

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 29, 2017
Enrollment StartFeb 11, 2020
Primary CompletionJul 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.6 years ago

Interventions

Mesenchymal Stem Cellsbiological

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.