MedTrace Logo

Perinatal Arterial Stroke Treated With Stromal Cells Intranasally

NCT03356821 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Perinatal Arterial Ischemic Stroke
  • Neonatal Stroke

Interventions

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Manon Benders, MD, PhD · UMC Utrecht

  • Floris Groenendaal, MD, PhD · UMC Utrecht

  • Frank van Bel, MD, PhD · UMC Utrecht

  • Cora Nijboer, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2021-07-27
Completion
2021-07-27

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356821 on ClinicalTrials.gov