Clinical trial NCT07018739: Mesenchymal Stem Cells With Therapeutic Hypothermia for Infants With Perinatal Hypoxic-Ischemic Encephalopathy
Official title: Efficacy of Using Mesenchymal Stem Cells With Therapeutic Hypothermia in Infants With Perinatal Hypoxic-Ischemic Encephalopathy: A Double-Blinded, Randomized-Control Trial (Pilot Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Perinatal Anoxic-ischemic Brain Injury
Mesenchymal Stem Cell
Keywords: Perinatal HIE
Mesenchymal stem cells
Wharton&amp;#39;s jelly
therapeutic hypothermia
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
First posted: 2025-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perinatal hypoxic-ischemic encephalopathy (HIE) remains a significant cause of neonatal morbidity and mortality. While therapeutic hypothermia (TH) has been established as the standard treatment, many infants continue to experience adverse neurodevelopmental outcomes. Mesenchymal stem cells (MSCs), known for their neuroprotective, anti-inflammatory, and regenerative properties, offer a promising adjunctive therapy.

The goal of this study is to evaluate the safety and feasibility of administering allogeneic Wharton's jelly-derived MSCs administered intravenously in neonates with moderate to severe HIE after receiving TH. The study population includes infants ≥34 weeks gestation diagnosed with moderate to severe HIE who have completed TH and are clinically stable.

The main questions it aims to answer are:

Does intravenous MSC administration after therapeutic hypothermia reduce the risk of death or neurological disability at 1 year of age compared to placebo? Does this intervention improve neurodevelopmental outcomes at 2 years of age? Researchers will compare infants randomized to receive MSCs with those receiving placebo to assess clinical safety, mortality, and neurodevelopmental outcomes.

Participants will:

Be randomly assigned to receive either a daily intravenous dose of MSCs or placebo for 3 consecutive days, with the first dose administered within the first 10 days of life.

Be monitored for immediate adverse events and vital signs during and after each administration.

Undergo serial follow-up assessments including neuroimaging at 1 month and neurodevelopmental evaluations at defined intervals up to 2 years of age.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Major congenital anomalies or genetic syndromes
* Severe sepsis or active infection
* Severe coagulopathy or bleeding disorders
* Multi-organ failure

Primary outcomes:
measure: Death or neurological disability
timeFrame: From enrollment to 12 months postnatal age
Secondary outcomes:
measure: Death or neurological disability
timeFrame: From enrollment to 24 months postnatal age
measure: MR-detected brain injury
timeFrame: at 1 months if age
measure: Severe adverse events
timeFrame: from drug administration until hospital discharge or postnatal age of 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
References:
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