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Study on the Effectiveness of Autologous Stem Cell Transplantation with Cytarabine in Patients with Aggressive Multiple Sclerosis

Verified siteRegistered drugNo 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 is focused on studying the effects of a treatment for Multiple Sclerosis (MS), specifically a type known as Relapsing Remitting Multiple Sclerosis. The study aims to observe the disease activity over a period of 36 months. The treatment involves a process called Autologous Hematopoietic Stem Cell Transplantation (AHSCT), which is a procedure where a patient's own stem cells are used to help reset the immune system. This study will also involve the use of medications such as Natalizumab, Alemtuzumab, Ocrelizumab, and Ofatumumab, which are known as disease-modifying treatments. These medications are administered through intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to determine if this treatment can lead to no evidence of disease activity in patients with aggressive forms of MS. Participants will be monitored for any signs of disease activity, such as relapses or new brain lesions, using methods like MRI scans. The study will also track any changes in disability levels and overall health over the course of the trial. Participants may receive either the active treatment or a placebo, and their progress will be compared to assess the effectiveness of the treatment.

Throughout the study, various health parameters will be measured, including the number of new brain lesions, changes in brain volume, and the presence of certain proteins in the blood and cerebrospinal fluid. The study will also look at the impact of the treatment on quality of life, fatigue, and walking ability. The trial is expected to run until 2030, with the goal of providing valuable insights into the management of aggressive MS.

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 assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current health status.

    A series of tests and evaluations will be performed to establish a baseline for your health and the current state of your multiple sclerosis.

  2. Step 2

    Treatment preparation

    Before starting the main treatment, you will receive medications to prepare your body. This may include drugs to protect your organs and manage side effects.

    You will be informed about the specific medications and their purposes during this phase.

  3. Step 3

    Stem cell collection

    Your own stem cells will be collected for later use. This process involves stimulating your body to produce more stem cells, which are then collected from your blood.

  4. Step 4

    Conditioning treatment

    You will receive a combination of medications to prepare your body for the stem cell transplant. These medications include cyclophosphamide, cytarabine, carmustine, and melphalan flufenamide, administered through an intravenous drip.

    This phase is crucial for eliminating the existing immune cells that are causing damage in multiple sclerosis.

  5. Step 5

    Stem cell transplantation

    The collected stem cells will be infused back into your body through an intravenous drip. This process is similar to receiving a blood transfusion.

    The goal is to rebuild your immune system with healthy cells.

  6. Step 6

    Recovery and monitoring

    After the transplant, you will be closely monitored for any signs of complications or side effects. This includes regular blood tests and health assessments.

    You will receive medications such as filgrastim to support your recovery and help your body produce new blood cells.

  7. Step 7

    Follow-up assessments

    Regular follow-up visits will be scheduled to assess your progress and the effectiveness of the treatment. These visits will occur at 12, 24, and 36 months after the transplant.

    During these visits, various tests will be conducted to monitor your multiple sclerosis activity and overall health.

Who can join the trial?

6 criteria

  • Must have a diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald's criteria. This is a specific way doctors diagnose this type of multiple sclerosis.
  • Must have treatment-resistant MS. This means the disease is still active even after at least 6 months of treatment with certain medications in the past year. Disease activity is shown by:
    • Having at least one relapse, which is a return or worsening of symptoms.
    • Having new signs of disease on an MRI scan, which is a type of imaging test. This includes new or active lesions in the brain.
    • Must be between the ages of 18 and 55.
    • Must have a score between 2.0 and 6.0 on the Expanded Disability Status Scale (EDSS). This scale measures the level of disability in people with multiple sclerosis.
    • Must be a candidate for treatment with at least one of the following disease-modifying treatments (DMT): natalizumab, alemtuzumab, ocrelizumab, and/or ofatumumab. This means you should not have failed previous treatments with these medications and should not have any medical reasons that prevent you from using them.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of multiple sclerosis other than Relapsing Remitting Multiple Sclerosis cannot participate.
  • Patients who are under 18 years old or over 65 years old cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days cannot participate.
  • Patients who have a history of severe allergic reactions to any of the study medications cannot participate.
  • Patients who have any other serious health conditions that might interfere with the study cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

Autologous Hematopoietic Stem Cell Transplantation is a therapy used in this clinical trial for patients with aggressive multiple sclerosis. In this treatment, doctors collect stem cells from the patient's own blood or bone marrow. These stem cells are then stored while the patient undergoes high-dose chemotherapy to eliminate the diseased cells in the body. Afterward, the stored stem cells are returned to the patient's body to help rebuild a healthy immune system. This therapy aims to stop the progression of multiple sclerosis by resetting the immune system.

What is already known about the treatment

Autologous Hematopoietic Stem Cell Transplantation – This treatment involves collecting a patient's own stem cells, which are then reintroduced into their body after intensive therapy. It is currently being studied for its effectiveness in treating aggressive forms of multiple sclerosis, particularly relapsing-remitting multiple sclerosis. The main goal is to achieve no evidence of disease activity over a period of 36 months. The procedure works by resetting the immune system, which is thought to be attacking the nervous system in multiple sclerosis. It is classified as a form of regenerative medicine, aiming to restore normal function by replacing damaged cells.

Investigated diseases

Relapsing Remitting Multiple Sclerosis – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During these relapses, inflammation damages the protective covering of nerve fibers in the central nervous system, leading to a variety of symptoms such as fatigue, numbness, vision problems, and difficulty with coordination and balance. The disease progresses with alternating periods of relapses and remissions, where symptoms may improve or disappear entirely. Over time, some individuals may experience a gradual worsening of symptoms, even during remission periods. The frequency and severity of relapses can vary greatly among individuals. As the disease advances, it may lead to more persistent symptoms and disability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515470-26-00Protocol codeNET-MSEstimated enrolment90 patientsSponsorFondazione Italiana Sclerosi Multipla Ente Del Terzo Settore/et S

sourced from the EU Clinical Trials Register and site verification

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