BridgeMD
iSTOP-CP
EU CTIS ID: 2025-521506-17-01
What this study is testing
The main objective of this study is to determine whether intranasal stem cell therapy (IN-MSC) can effectively reduce brain damage and improve motor outcomes in newborns with hypoxic-ischemic brain injury (HIBI). By conducting a placebo-controlled phase II clinical trial in infants with MRI confirmed HIBI, this trial wants to see if the treatment is effective and safe with the goal to eventually incorporate the therapy in standard clinical care.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Neonate with a gestational age ≥35.0 weeks at birth
- Either a PAIS (a neurologic condition characterized by focal cerebral ischemia and infarction following blockage of a brain artery with impairment of blood supply and oxy-genation of brain tissue, clinically characterized by seizures (clinical or subclini-cal), respiratory difficulties, or both) or PA (defined as at least one out of the following: 5-min Apgar score ≤ 5, Resuscitation, Mechanical ventilation following resuscitation ≥ 10 minutes after birth, pH <7.0, BE <-16 mmol/L, or lactate > 10.0 mmol/L in umbilical cord blood sample, or in arterial, venous or capillary blood gas sample obtained within 1 hour after birth) diagnosis
- Showing signs of hypoxic-ischemic injury in the following predefined brain areas (indicated by DWI restriction and/or abnormal ADC values and/or 1H-MRS lactate/N-acetyl aspartate (NAA) and/or NAA/Choline ratio abnormalities): PLIC (posterior limb of the internal capsule), central gray matter (BGT: basal ganglia and/or thalami), rolandic cortex, cerebral peduncles, white matter involving CST (corticospinal tract)
- Written informed consent from custodial parent(s)
You likely can't join if
- Suspicion of chromosomal anomaly, metabolic disorder, genetic syndrome, congenital central nervous system (CNS) malformation, congenital CNS infection and main injury intracranial haemorrhage
- Once a clinical team decides on withdrawal of NICU care, the patient is not eligible for inclusion: infants with very severe brain injury on MRI and need for ventilation support (not breathing independently), who have a prognosis of severely multiple handicaps and/or no realistic prospect of survival at the discretion of the attending physician, will not be eligible to iSTOP-CP, to avoid unnecessary suffering and an unacceptable quality of life
- Contraindications for intranasal administration of medication, including nasal obstruction (e.g. choanal atresia), nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal damage
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.