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Study on Human Fetal Neural Precursor Cells and Tacrolimus for Patients with Progressive 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 Progressive Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, leading to a gradual worsening of symptoms. The study will explore the effects of a treatment involving the transplantation of human fetal neural precursor cells, which are special cells that can develop into different types of brain cells. These cells will be administered as a solution for infusion directly into the spinal fluid, a method known as intrathecal administration. The purpose of the study is to evaluate the effectiveness of this cell therapy compared to a sham procedure, which is a simulated treatment that does not contain active cells.

Participants in the study will receive two doses of the cell therapy, six months apart. The study will last for a total of 96 weeks, during which various assessments will be conducted to monitor changes in brain volume and other health indicators using magnetic resonance imaging (MRI). The study will also track any side effects experienced by participants and evaluate changes in their cognitive function, which refers to mental processes like thinking and memory.

In addition to the cell therapy, the study will also involve the use of tacrolimus, a medication that helps suppress the immune system. This medication will be taken orally, meaning it is swallowed in pill form. The study aims to provide insights into whether this combination of treatments can help slow down or improve the symptoms of Progressive Multiple Sclerosis.

The research process

The trial runs in 8 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 is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include being between 18 and 65 years old, having a diagnosis of progressive multiple sclerosis, and meeting specific health and treatment history requirements.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. This involves magnetic resonance imaging (MRI) to evaluate brain volume and other health assessments.

  3. Step 3

    First treatment administration

    The first administration of human fetal neural precursor cells is given intrathecally, which means it is delivered into the space around the spinal cord. The dose consists of 200 million cells.

    This procedure is designed to assess the potential therapeutic effects of the cells in treating progressive multiple sclerosis.

  4. Step 4

    Oral medication

    During the study, tacrolimus is taken orally. The specific dosage and frequency are determined by the study protocol and are monitored by the study team.

  5. Step 5

    Six-month follow-up

    Six months after the first treatment, a follow-up assessment is conducted. This includes another MRI to evaluate any changes in brain volume and other health assessments.

  6. Step 6

    Second treatment administration

    A second administration of human fetal neural precursor cells is given intrathecally, with the same dosage as the first administration.

    This step is crucial for evaluating the long-term effects of the treatment.

  7. Step 7

    Ongoing monitoring

    Throughout the study, regular monitoring is conducted to track health status and any potential side effects. This includes periodic MRIs and other assessments.

    The study aims to observe changes in brain volume and other health indicators over a 96-week period.

  8. Step 8

    Final assessment

    At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of health status and a final MRI to measure any changes in brain volume.

    The results of this assessment contribute to understanding the effectiveness of the treatment.

Who can join the trial?

8 criteria

  • The participant must be willing and able to give informed consent to join the trial. This means they understand the study and agree to take part.
  • Both males and females can participate, and they must be between 18 and 65 years old.
  • The participant must have been diagnosed with **Progressive Multiple Sclerosis (PMS)**, which is a type of multiple sclerosis that gets worse over time. The diagnosis should follow specific guidelines known as the 2017 revised McDonald criteria.
  • The participant's **EDSS** (Expanded Disability Status Scale) score should be between 3.0 and 8.0 at the time of screening. The EDSS is a method used to measure the level of disability in people with multiple sclerosis.
  • The participant must have experienced failure, intolerance, or ineligibility to approved therapies. This means their condition has worsened despite treatment, they couldn't tolerate the treatment due to side effects, or they are not suitable for the available treatments.
  • The participant must be able to take oral medication and be willing to follow the study procedures.
  • Females who can have children must use highly effective birth control for at least one month before the screening and agree to continue using it during the study.
  • Males who can father children must use an effective birth control method and agree not to donate sperm for the entire duration of the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have Progressive Multiple Sclerosis cannot participate. This is a type of multiple sclerosis where symptoms gradually get worse over time.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to receive two treatments six months apart cannot participate. The treatment involves injecting cells into the space around the spinal cord.
  • Patients who are not able to undergo a procedure that mimics the treatment without actually receiving it (called a sham procedure) cannot participate. This is used to compare the effects of the actual treatment.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

hfNPCs are human fetal neural stem cells used in this clinical trial. These cells are transplanted into patients with progressive multiple sclerosis to assess their potential therapeutic benefits. The trial involves administering these cells directly into the spinal fluid, which is known as an intrathecal administration. The goal is to see if these stem cells can help improve or stabilize the condition of patients with progressive multiple sclerosis.

What is already known about the treatment

Human Fetal Neural Progenitor Cells (hfNPCs) – This treatment involves the administration of human fetal neural progenitor cells through intrathecal injections, which are given directly into the spinal canal. Currently, this approach is being studied in clinical trials for its potential to treat progressive multiple sclerosis, a condition characterized by worsening neurological function. The main therapeutic goal is to assess whether these cells can help repair or regenerate damaged nerve tissues. At the molecular level, hfNPCs are believed to support neural repair by differentiating into various types of neural cells and releasing factors that promote cell survival and growth. This treatment falls under the category of regenerative medicine, focusing on restoring function by replacing or repairing damaged cells.

Investigated diseases

Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not have clear periods of remission. The disease affects the central nervous system, leading to symptoms such as muscle weakness, difficulty with coordination and balance, and cognitive changes. As the disease progresses, individuals may experience increased disability and challenges in daily activities. The progression can vary significantly among individuals, with some experiencing a steady decline and others having periods of stability. The exact cause of the disease is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511028-15-00Protocol codeSTEMS2Estimated enrolment86 patientsSponsorOspedale San Raffaele S.r.l.

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