Mesenchymal stem cells for neonatal stroke

Phase 1

• Conditions: Perinatal arterial Ischemic Stroke (PAIS); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001912-20-NL
• Lead Sponsor: niversity Medical Center Utrecht, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-09
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- (Near-)Term infants, =36+0 weeks of gestation, admitted to one of the Dutch NICUs, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms.
- PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery
- Written informed consent from custodial parent(s)
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified