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NCT number NCT03356821
Study type Interventional
Source UMC Utrecht
Contact Linda S. de Vries, MD, PhD
Phone +31(0)887554545
Email l.s.devries@umcutrecht.nl
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date January 2018
Completion date November 2019

Clinical Trial 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.


Clinical Trial Description

Perinatal arterial ischemic stroke (PAIS) is an important perinatal cause of long-lasting neurodevelopmental problems. Recent studies report an incidence of PAIS of 1 per 2300 full-term infants born alive. Adverse consequences of PAIS include hemiplegia, cognitive dysfunction, epilepsy and speech problems. In 50-75% of infants, neonatal stroke leads to abnormal neuromotor and -developmental outcome or epilepsy. The estimated annual mortality rate of neonatal stroke is 3.49/100,000 annually. Current treatment options for PAIS mainly focus on controlling convulsions and associated infections. There is no treatment available that leads to reduction of neonatal brain damage in this severely affected group of infants. This leads to life-long consequences of PAIS and forms a large burden for patients and society. The overall aim of this project is to meet this need by developing a cell based treatment strategy. Animal models of neonatal brain injury provide evidence for the feasibility and efficacy of intranasal mesenchymal stromal cell (MSC) application in the treatment of PAIS. Additionally, results from human trials with MSCs in the treatment of adult stroke or other pathologic conditions provide evidence that MSC treatment is safe. This project aims at making the first step towards clinical application of MSCs to treat PAIS. Successful completion of this project will provide the first evidence of the safety and feasibility of MSCs to treat brain damage in newborn infants. 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 Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Completed NCT01637129 - Transcranial Magnetic Stimulation in Children With Stroke Phase 1
Recruiting NCT03171818 - Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration Phase 2