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Study of Mesenchymal Stromal Cells Treatment for Patients with Traumatic Brain Injury: A Safety and Effectiveness Trial

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 clinical trial studies a treatment for traumatic brain injury using mesenchymal stromal cells (also known as stem cells). These cells are specially prepared in a laboratory and given to patients through infusion into their bloodstream. The study aims to determine if this cell treatment is safe and effective for people with severe brain injuries.

The treatment involves giving patients either mesenchymal stromal cells or a placebo. Two different amounts of cells will be tested: 80 million cells or 160 million cells. The treatment must be given within 48 hours after the brain injury occurs. During the study, doctors will monitor changes in the brain using special blood tests and magnetic resonance imaging (MRI) scans.

Patients will be followed for one year after receiving the treatment. Throughout this time, doctors will check how well the brain is healing and monitor the patient's recovery progress. They will use various tests to measure improvements in brain function and overall quality of life. The study will help determine if this new cell treatment can reduce brain damage in people who have experienced severe head injuries.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Within 48 hours after traumatic brain injury, you will receive either mesenchymal stromal cells (stem cells) or placebo through an infusion

    The treatment consists of a single infusion containing either 80 million or 160 million cells in a solution, or a placebo solution

  2. Step 2

    Early monitoring period

    Your brain pressure will be monitored through an already inserted or planned monitoring device

    Blood samples will be collected to measure markers of brain injury and inflammation

  3. Step 3

    Two-week follow-up

    At day 14 (plus or minus 3 days), you will undergo a magnetic resonance imaging (MRI) scan

    Blood tests will be performed to measure levels of specific proteins that indicate brain injury

  4. Step 4

    Six-month evaluation

    At 6 months (plus or minus 15 days), you will have another MRI scan

    You will complete assessments to evaluate your recovery progress

    Tests will include evaluation of your overall outcome and quality of life

  5. Step 5

    Final assessment

    At 12 months (plus or minus 15 days), you will have a final MRI scan

    Final assessments will be conducted to measure your recovery progress

    The evaluation will include tests to assess your overall outcome and quality of life after brain injury

Who can join the trial?

7 criteria

  • Age between 18 and 70 years old
  • Must have a Clinical Frailty Index (CFI) score less than 5 (CFI measures a person's level of fitness and ability to perform daily activities)
  • Must have confirmed brain injury visible on CT scan showing trauma-related changes (Marshall's CT Classification score greater than 1)
  • Must be able to receive treatment within 48 hours after the brain injury
  • Must have a Glasgow Coma Scale (GCS) score of 8 or lower when entering the study (GCS measures consciousness level) and at least one pupil must react to light
  • Must have intracranial pressure (ICP) monitoring already in place or planned as part of regular medical care (ICP monitoring measures pressure inside the skull)
  • Body weight must be between 40 and 100 kilograms

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Pregnancy or breastfeeding women
  • Previous history of traumatic brain injury
  • Presence of active infections or diseases that could affect the brain
  • Current participation in other clinical trials
  • Known allergies to medications used in the study
  • Inability to provide informed consent (either directly or through a legal representative)
  • Severe systemic diseases that could interfere with the treatment
  • History of cancer in the past 5 years
  • Severe blood clotting disorders
  • Unstable vital signs that cannot be managed medically
  • Major psychiatric disorders that could affect participation
  • Active substance abuse or addiction
  • Conditions that would prevent follow-up visits
  • Use of medications that could interfere with the study treatment
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Investigated drugs

  • Mesenchymal Stromal Cells (MSCs)

    These are special cells that can help repair damaged tissue. In this trial, they are being studied as a potential treatment for traumatic brain injury. MSCs are natural cells that have healing properties and can potentially reduce brain damage. They work by promoting tissue repair and reducing inflammation in the injured brain. The cells are administered to patients to evaluate if they can help improve recovery after severe brain trauma.

  • Placebo

    A placebo is an inactive substance that contains no therapeutic ingredients. It is used as a control to compare with the active treatment (MSCs) to determine if the real treatment is effective. Patients receiving the placebo undergo the same procedures but without receiving the actual therapeutic cells.

What is already known about the treatment

Mesenchymal Stromal Cells (MSCs) – A type of cellular therapy administered through infusion for treating severe traumatic brain injury. These cells are derived from human tissue and represent an advanced therapeutic approach currently being investigated in Phase II clinical trials. MSCs work by potentially reducing brain damage through their anti-inflammatory properties and ability to promote tissue repair at the molecular level, as measured by specific biomarkers like NFfL (Neurofilament light chain) in the blood. This experimental treatment belongs to the class of regenerative medicine therapies and is being studied at two different dosage levels (80 and 160 million cells) to determine both safety and effectiveness in patients with severe traumatic brain injuries.

Investigated diseases

Traumatic Brain Injury - A condition that occurs when an external force causes damage to the brain. The injury happens when the head suddenly and violently hits an object or when an object pierces the skull and enters brain tissue. Initial damage can be followed by secondary injury, which includes changes in brain chemistry and blood flow. This condition can affect cognitive functions, physical abilities, and consciousness levels. The effects can range from mild to severe, depending on the extent of brain damage. Brain tissue may become bruised, torn, or experience bleeding.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516510-38-00Protocol codeMATRIxEstimated enrolment78 patientsSponsorFondazione IRCCS San Gerardo Dei Tintori

sourced from the EU Clinical Trials Register and site verification

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