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Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy

ConditionsHypoxic-Ischemic Encephalopathy, NeonatalBrain Injuries, Hypoxic-Ischemic
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-9
SponsorMahidol University

About this trial

Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth. Standard treatment with cooling therapy (therapeutic hypothermia) lowers the risk of death or disability, but many infants still suffer long-term problems.

This study will test whether adding stem cell therapy after cooling can further improve outcomes. The stem cells are taken from donated human placentas (Wharton's jelly-derived mesenchymal stem cells, MSCs). The cells are prepared under strict laboratory standards and checked for safety.

Infants with moderate to severe HIE who have completed cooling will be randomly assigned to receive either three intravenous infusions of MSCs or placebo within the first 10 days of life. Each infusion is given over about 30 minutes while the infant is closely monitored.

Researchers will follow participants for up to 2 years. The main outcome is whether MSC treatment can reduce the combined risk of death or serious developmental delay at 1 year of age. The study will also track brain MRI findings, safety events, and developmental progress at 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Term and late-preterm infants (gestational age ≥34 weeks)

Diagnosed with moderate to severe HIE based on modified Sarnat staging

Received TH per standard protocol

Parental consent obtained

Disqualifiers

Major congenital anomalies or genetic syndromes

Severe sepsis or active infection

Severe coagulopathy or bleeding disorders

Multi-organ failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wharton's jelly-derived mesenchymal stem cells

    Biological/Vaccine

    MSCs (2x10\^6 cells/kg) in 10 mL 0.9%normal saline administered intravenously within 10 days, postnatally after TH completion, every 24 hours for 3 consecutive days

  • 0.9 % Normal Saline

    Drug

    0.9% normal saline 10 mL administered intravenously within 10 days, postnatally after TH completion, every 24 hours for 3 consecutive days

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Wharton's jelly-derived mesenchymal stem cellsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Death or neurological disability

Including any causes of deaths. Neurological disability is defined by Bayley Scales of Infant Development-IV \<70 (ranging from 40 to 160, with higher scores indicating better neurodevelopmental outcomes)

Time frame
At 12 months of age

Secondary outcomes

1

Death or neurological disability

Any causes of death. Neurological disability is defined as Bayley Scales of Infant Development-IV \<70 (ranging from 40 to 160, with higher scores indicating better neurodevelopmental outcomes)

Time frame
At 24 months postnatal age
2

MR-detected brain injury

Brain injury detected by Weeke MRI score on brain MRI (total score range 0-57; higher scores indicate worse outcomes).

Time frame
At 1 month of age
3

Severe adverse events

One of these adverse events occurring after drug initiation: Hemodynamic instability (persistent HR \>180 beats per minute, BP \<5th %tile for gestational age and postnatal age, require new treatment (volume resuscitation/inotropic agents/vasopressor agents) Acute liver failure (new-onset of hyperbilirubinemia with INR ≥3 with no response to vitamin K administration) Thrombosis (any events such as renal vein thrombosis, stroke) Death before discharge

Time frame
From first study infusion until hospital discharge, up to 12 months
4

HLA antibody formation

Presence of anti-HLA antibodies assessed by panel-reactive antibody (PRA) testing.

Time frame
At 9-12 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Siriraj Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: