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Study on the Use of Mesenchymal Stem Cells and Sodium Chloride for Patients with Progressive Multiple Sclerosis

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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 new treatment for Multiple Sclerosis (MS), a disease that affects the brain and spinal cord, leading to a range of symptoms such as difficulty walking, fatigue, and vision problems. The treatment being tested involves the use of Mesenchymal stem cells, which are special cells that can develop into different types of cells in the body and may help repair damaged tissues. These cells are injected into the space around the spinal cord, a method known as intrathecal injection.

The purpose of the study is to explore whether this treatment can help regenerate nerve cells and improve the condition of patients with progressive forms of MS. Participants in the study will receive either the stem cell treatment or a placebo. The study will monitor changes in the participants' condition over time, using various tests to assess nerve function and brain health.

The study will last for several months, with regular check-ups to track progress and any changes in symptoms. Participants will be closely monitored for any side effects or improvements in their condition. The goal is to determine if the stem cell treatment can offer a new way to manage and potentially improve the lives of those living with progressive MS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of multiple sclerosis, and disease duration.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes various tests to evaluate neurological function and overall health.
Step 3
Treatment administration
The treatment involves the administration of mesenchymal stem cells through an intrathecal injection. This means the cells are injected into the space around the spinal cord.
A sodium chloride solution is used as a control in some cases. This is administered as an intravenous infusion.
Step 4
Follow-up assessments
Follow-up assessments occur at 6 and 12 months to measure changes in neurological function and other health indicators.
These assessments include tests such as visual function, brain imaging, and physical performance evaluations.
Step 5
Monitoring and reporting
Throughout the study, any adverse events or changes in health are monitored and reported.
Regular check-ups are conducted to ensure safety and track progress.
Step 6
Study completion
The study is expected to conclude by March 2027.
Final assessments are conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

5 criteria

Be between the ages of 18 and 55 years old.
Have a diagnosis of **secondary progressive** or **primary progressive** **multiple sclerosis (MS)**. This means the disease is getting worse over time.
Have an **EDSS score** between 4 and 7. The **EDSS** is a scale used to measure how much MS affects your ability to move and do daily activities.
Have had the disease for 2 to 18 years.
Provide a signed, written informed consent. This means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of progressive multiple sclerosis cannot participate. This is a type of multiple sclerosis where symptoms gradually worsen 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 part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for the safety and effectiveness of the study.

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Verified sites

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Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Mesenchymal Autologous Stem Cells (MSCs) are being studied as a regenerative treatment for Multiple Sclerosis (MS). In this trial, the stem cells are taken from the patient's own body, processed, and then reintroduced into the patient. The goal is to see if these cells can help repair or regenerate damaged nerve tissues in patients with progressive MS. The treatment is administered directly into the spinal fluid to target the central nervous system more effectively.

What is already known about the treatment

Mesenchymal Autologous Stem Cells – This treatment involves the administration of stem cells derived from the patient's own body, delivered directly into the spinal canal through a procedure known as intrathecal injection. Currently, this approach is being explored in clinical trials as a potential regenerative therapy for multiple sclerosis, a condition affecting the nervous system. The main therapeutic goal is to promote nerve repair and regeneration, potentially improving neurological function in patients. At the molecular level, these stem cells are believed to support tissue repair by modulating the immune response and promoting the growth of new nerve cells. This treatment falls under the category of regenerative medicine, focusing on restoring function by repairing damaged tissues.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by damage to the protective covering of nerve fibers, known as myelin, which disrupts communication between the brain and the rest of the body. Symptoms can vary widely and may include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses with periods of relapses and remissions, or it may steadily worsen over time. The exact cause of multiple sclerosis is unknown, but it is believed to involve an abnormal immune response. Environmental factors and genetic predisposition may also play a role in its development.