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A study testing Wharton's jelly-derived mesenchymal stem cells with spinal cord stimulation for adults with chronic spinal cord injury

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 looks at traumatic spinal cord injury that has lasted for more than one year. A spinal cord injury happens when damage occurs to the bundle of nerves inside the spine that carries messages between the brain and the rest of the body. When this injury is chronic, it means it has been present for a long time. The study will use a treatment called Wharton's jelly-derived mesenchymal stem cells, which are special cells that come from a part of the umbilical cord and may help repair damaged tissue. These cells will be given through intrathecal infusion, which means they will be delivered directly into the fluid that surrounds the spinal cord. Along with the stem cell treatment, participants will receive intensive rehabilitation therapy that includes transcutaneous spinal cord stimulation, which uses mild electrical signals applied through the skin to help activate the spinal cord and improve function.

The purpose of this study is to check if this combined treatment is safe and practical to use in people with chronic spinal cord injury. The study will carefully watch for any unwanted effects or complications that might occur during or after the treatment. It will also look at whether the treatment causes any worsening of movement, sensation, or body functions that are controlled automatically, such as blood pressure and temperature regulation. Additionally, the study will examine samples of the fluid around the spinal cord to see if the body develops any immune reactions to the stem cells.

During the study, participants will receive the stem cell infusions at specific times and will take part in the rehabilitation program with electrical stimulation. The study team will track whether participants are able to follow the treatment plan and complete all the required visits and procedures. They will also note any practical difficulties that come up when combining these two types of treatment. Throughout the entire process, doctors will monitor participants closely using physical examinations, measurements of vital signs like heart rate and blood pressure, and laboratory tests to ensure safety and gather information about how well this approach works in a real medical setting.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase with stem cell infusions

    During this phase, you will receive intrathecal infusions of stem cells. Intrathecal means the medication will be delivered directly into the space around your spinal cord through a needle inserted into your lower back.

    The stem cells used are called Wharton's jelly-derived mesenchymal stem cells. These are special cells obtained from umbilical cord tissue that have the ability to support tissue repair.

    The stem cells will be given as a solution for infusion, which is a liquid form of the medication.

    You will receive a total of three infusions during the study. The first infusion will occur at the beginning, and the third infusion will be administered at week 9.

    The exact dosage and frequency between infusions will be determined according to the study protocol.

  2. Step 2

    Intensive rehabilitation with spinal cord stimulation

    Alongside the stem cell treatment, you will participate in an intensive neurorehabilitation program.

    This program includes transcutaneous spinal cord stimulation, also called tSCS. This is a technique where small electrical currents are applied to your skin over the spinal cord area to help stimulate nerve activity.

    The rehabilitation sessions will be conducted throughout your participation in the study.

  3. Step 3

    Safety monitoring and testing of spinal fluid

    Throughout the study, your safety will be closely monitored. Any adverse events, which are unwanted or harmful reactions, will be recorded.

    Your cerebrospinal fluid, the liquid that surrounds your brain and spinal cord, will be sampled and analyzed. This will happen after the first infusion at week 1 and after the third infusion at week 9.

    These samples will be checked for anti-HLA antibodies, which are substances your immune system might produce in response to the stem cells. This helps determine if your body is having an immune reaction to the treatment.

  4. Step 4

    Regular assessments of your condition

    Your motor function, which refers to your ability to move, will be assessed regularly using standardized evaluation tools.

    Your sensory function, which is your ability to feel sensations, will also be evaluated throughout the study.

    Your autonomic functions, which control automatic body processes like blood pressure and bladder control, will be monitored.

    These assessments will use validated tools such as the ASIA Scale, a standard method for evaluating spinal cord injury.

    Specific neurophysiological tests, which measure the electrical activity of your nerves and muscles, will also be performed.

  5. Step 5

    Physical examinations and vital signs monitoring

    You will undergo regular physical examinations to check your overall health status.

    Your vital signs, including blood pressure, heart rate, temperature, and breathing rate, will be measured at scheduled intervals.

    These measurements help ensure your safety throughout the treatment period.

  6. Step 6

    Laboratory tests

    Blood samples and other laboratory tests will be collected at various time points during the study.

    These tests help monitor your general health and detect any changes that might be related to the treatment.

  7. Step 7

    Follow-up visits

    You will be required to attend scheduled follow-up visits throughout your participation in the study.

    These visits are necessary to complete all assessments and monitoring procedures.

    The study is expected to continue until approximately August 2027.

Who can join the trial?

9 criteria

  • You must have a single spinal cord injury caused by trauma, which means damage to your spinal cord from an accident or physical injury, with a severity level classified as AIS grade A, B, or C, where AIS is a scale that measures how much movement and feeling you have below the injury site.
  • Your spinal cord injury must be confirmed to be located in the cervical or thoracic levels, meaning the neck or upper back area between C1 and T12, based on a doctor's examination and previous scans such as MRI or CT.
  • Your spinal cord injury must have occurred more than 1 year ago, meaning you have been living with this injury for at least one year.
  • You must be between 18 and 70 years old.
  • Your life expectancy must be greater than 2 years, meaning doctors expect you to live for more than 2 years.
  • You must be able to attend follow-up visits and take part in all study procedures as required.
  • You must provide written informed consent, which means you agree in writing to participate in the study after understanding what it involves.
  • You must have adequate cognitive capacities, meaning you have the mental ability to understand what the study is about and make an informed decision to participate.
  • You must be willing to comply with all therapeutic protocols and study procedures, meaning you agree to follow all treatment plans and requirements of the study.

Who cannot join the trial?

1 criterion

  • The exclusion criteria for this clinical trial have not been provided in the available information. This means the specific reasons why a patient cannot participate in this study are not listed in the current documentation.
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Investigated drugs

  • Wharton's jelly-derived mesenchymal stem cells

    are special cells taken from a part of the umbilical cord called Wharton's jelly. These cells have the ability to develop into different types of cells and may help repair damaged tissue. In this trial, they are given directly into the fluid surrounding the spinal cord through a procedure called intrathecal infusion. The goal is to see if these cells can help improve recovery in people with spinal cord injuries.

  • Transcutaneous spinal cord stimulation

    is a treatment that uses mild electrical currents applied through the skin to stimulate the spinal cord. Small electrode patches are placed on the skin over the spine, and these deliver gentle electrical pulses. This stimulation is used along with intensive rehabilitation exercises. The aim is to help activate nerve pathways in the spinal cord that may improve movement and function in people with spinal cord injuries.

What is already known about the treatment

Wharton's Jelly-Derived Mesenchymal Stem Cells – This is an experimental treatment administered through intrathecal infusion, which means it is delivered directly into the spinal canal surrounding the spinal cord. These stem cells are extracted from Wharton's jelly, a soft tissue found in the umbilical cord, and are currently being studied in clinical trials for their potential to help repair damaged nerve tissue in people with chronic spinal cord injuries. The cells work by releasing special proteins and growth factors that may reduce inflammation, protect surviving nerve cells, and potentially encourage the formation of new connections in the injured spinal cord. This therapy belongs to the class of regenerative medicine treatments and is being investigated in combination with rehabilitation techniques to improve motor, sensory, and autonomic functions in patients who have experienced traumatic spinal cord injury.

Investigated diseases

Traumatic Spinal Cord Injury – Traumatic spinal cord injury is damage to the spinal cord resulting from physical trauma, such as accidents, falls, or violent impacts. The injury disrupts the normal transmission of nerve signals between the brain and the rest of the body. Depending on the location and severity of the damage, individuals may experience loss of movement, sensation, and control over certain body functions below the injury site. The condition can be classified as complete, where there is no function below the injury level, or incomplete, where some nerve signals can still pass through the damaged area. In chronic cases, the injury has stabilized but permanent changes in motor, sensory, and autonomic functions typically remain. The spinal cord's limited ability to repair itself means that functional impairments often persist long-term.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521877-14-00Protocol code2025-521877-14-00Estimated enrolment10 patientsSponsorFundacio Institut Guttmann

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