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Study of Autologous Cord Blood Stem Cells Treatment for Newborns with Hypoxic-Ischemic Encephalopathy

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating newborns with neonatal hypoxic-ischemic encephalopathy, a serious condition where the baby's brain doesn't receive enough oxygen and blood around the time of birth. The treatment being tested uses autologous cord blood stem cells, which are special cells collected from the baby's own umbilical cord blood.

The study aims to determine if using these stem cells is safe and possible as a treatment option for newborns with brain injury caused by oxygen deprivation. The treatment involves giving the processed stem cells back to the baby through intravenous infusion, which means the cells are delivered directly into the bloodstream.

During the study, babies will receive their own cord blood cells that have been specially prepared as a medical treatment. The treatment is given alongside standard cooling therapy (therapeutic hypothermia) that these babies typically receive. Doctors will monitor the children's development and check for any effects of the treatment for up to two years after the procedure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Your treatment begins with therapeutic hypothermia within the first 6 hours after birth

    During this time, doctors will monitor your brain activity using special equipment (EEG or aEEG)

    Your cord blood will be collected and processed to prepare the treatment

  2. Step 2

    Cell preparation and administration

    The medical team will prepare a special solution containing cord blood stem cells at a dose of 50 million cells per kilogram of body weight

    The prepared cells will be given through an intravenous infusion (through a vein)

  3. Step 3

    Short-term monitoring

    Medical staff will monitor your condition closely to check for any immediate reactions to the treatment

    Various tests will be performed to ensure your safety

  4. Step 4

    Long-term follow-up

    Your development will be monitored for up to 2 years after the treatment

    Regular check-ups will assess your brain development and overall progress

    The study will continue until February 2028

Who can join the trial?

9 criteria

  • Baby must show signs of brain dysfunction (encephalopathy) within 6 hours after birth, with a severity score of 2 or higher on the Sarnat scale (a method doctors use to assess brain function in newborns)
  • Baby may need to have an abnormal brain activity recording (electroencephalogram or aEEG) within 6 hours of birth
  • Baby must be receiving cooling therapy (therapeutic hypothermia) to protect the brain
  • Mother must test negative for certain infections:
    • HIV (human immunodeficiency virus)
    • HTLV 1 or 2 (human T-cell lymphotropic virus)
    • Hepatitis B virus
    • Hepatitis C virus
    • Mother must have negative blood test for syphilis (a type of infection)
    • Parents must provide written permission (consent) for their baby to participate in the study

Who cannot join the trial?

10 criteria

  • Newborns with severe congenital abnormalities (birth defects present from birth)
  • Babies with confirmed genetic disorders
  • Infants who did not have their umbilical cord blood collected at birth
  • Newborns with active bleeding or severe blood clotting disorders
  • Babies with severe systemic infections (infections affecting the whole body)
  • Cases where parents or legal guardians do not provide informed consent
  • Infants with metabolic disorders (conditions affecting how the body processes food into energy)
  • Babies who have received other experimental treatments
  • Newborns with severe organ failure not related to the primary condition
  • Infants who cannot receive the full course of standard therapeutic cooling treatment
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Investigated drugs

Autologous cord blood stem cells are cells collected from a baby's umbilical cord blood at birth. These stem cells have the potential to repair damaged tissue and promote healing. In this treatment, the baby's own cord blood stem cells are used as a therapy to treat brain injury caused by oxygen deprivation during birth (hypoxic-ischemic encephalopathy). The stem cells are processed and then given back to the baby, working to potentially reduce brain damage and improve recovery.

What is already known about the treatment

Autologous Cord Blood Stem Cells - A therapeutic treatment derived from a newborn's own umbilical cord blood, which contains valuable stem cells that can be collected at birth and preserved for medical use. This treatment is administered through intravenous infusion and is currently being investigated in clinical trials for treating neonatal hypoxic-ischemic encephalopathy (brain injury caused by oxygen deprivation in newborns). The stem cells work by promoting tissue repair and reducing inflammation in damaged brain areas, potentially helping to restore normal brain function. This therapy belongs to the regenerative medicine class and represents an innovative approach to treating newborn brain injuries, with ongoing research focusing on its safety and effectiveness.

Investigated diseases

Neonatal hypoxic-ischemic encephalopathy - A brain injury that occurs in newborns due to reduced oxygen and blood flow to the brain during birth. The condition develops when a baby's brain doesn't receive enough oxygen and blood before, during, or shortly after birth. This oxygen deprivation can lead to damage of brain tissue. The effects can range from mild to severe, impacting various brain functions. The condition can affect movement, feeding, vision, hearing, and cognitive development in affected newborns.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-516421-30-00Estimated enrolment20 patientsSponsorCentre Hospitalier Regional De Marseille

sourced from the EU Clinical Trials Register and site verification

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