Recruiting

Study on the Safety and Effectiveness of MSV-allo for Patients with Lupus Nephritis

InvestigationalNo 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 lupus nephritis, a condition where the immune system attacks the kidneys, causing inflammation and damage. The treatment being tested is called MSV-allo, which is a type of cell therapy using mesenchymal cells. These cells are delivered through an injection into the bloodstream. The purpose of the study is to evaluate the safety and effectiveness of MSV-allo compared to a placebo in helping patients achieve either complete or partial remission of their symptoms.

Participants in the study will receive either the MSV-allo treatment or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The study will last for several months, with regular check-ups to monitor the participants' health and any changes in their condition. The main goal is to see how many patients experience improvement in their lupus nephritis symptoms by the end of the study period.

Throughout the study, researchers will also observe any changes in the use of medications like corticosteroids, which are often used to manage lupus nephritis. They will track whether participants can reduce their medication doses without worsening their condition. The study aims to provide valuable information on whether MSV-allo can be a safe and effective treatment option for people with lupus nephritis.

The research process

The trial runs in 7 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 specific criteria, including age, diagnosis of systemic lupus erythematosus, and lupus nephritis.
Written informed consent is required to participate.
Step 2
Screening visit
A screening visit is conducted to assess the current health status and confirm the diagnosis of lupus nephritis.
Vaccination against pneumococcus and influenza is verified.
Step 3
Treatment initiation
The treatment involves the administration of MSV-allo, a cell suspension for injection, given through an intravenous injection.
The objective is to evaluate the safety and effectiveness of MSV-allo compared to a placebo.
Step 4
Treatment duration
The treatment period lasts for 24 weeks.
During this time, the response to the treatment is monitored, focusing on achieving complete or partial remission of lupus nephritis.
Step 5
Monitoring and assessments
Regular assessments are conducted to monitor health status and treatment response.
The primary endpoint is the proportion of patients achieving a complete or partial response at week 24.
Step 6
Secondary assessments
Secondary assessments include evaluating changes in corticosteroid dosage, proteinuria levels, and quality of life scores.
The goal is to reduce the dose of prednisone-equivalent corticosteroids and assess any changes in disease activity.
Step 7
End of trial
The trial is estimated to conclude by December 26, 2025.
Final assessments are conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

Females or males aged 18 years or older who agree to participate by signing a consent form.
Have a diagnosis of **Systemic Lupus Erythematosus (SLE)**, which is a condition where the immune system attacks the body's own tissues. This diagnosis must meet specific criteria set by medical organizations.
Have a diagnosis of **Lupus Nephritis**, which is a kidney inflammation caused by lupus, confirmed by a kidney biopsy done within the last 6 months or 1 year, depending on the situation.
Have not fully responded to standard treatments, or have a moderate to severe return of lupus nephritis symptoms.
Have a **SLEDAI-2K** score of 10 or higher during the screening. This is a tool used to measure the activity of lupus in the body.
Women who can become pregnant must use effective birth control methods to prevent pregnancy during the study.
Must have received vaccinations against pneumococcus and influenza during the appropriate vaccination times.

Who cannot join the trial?

10 criteria

Patients who have a different kidney condition other than Lupus Nephritis cannot participate. Lupus Nephritis is a kidney inflammation caused by lupus, an autoimmune disease.
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, such as those who cannot give informed consent, are not eligible.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have any other medical condition that might interfere with the study results or their safety cannot participate.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have had a recent change in their lupus treatment that might affect the study results cannot participate.
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.

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Investigated drugs

MSV-allo® is a type of therapy that uses mesenchymal cells. These cells are a kind of stem cell that can help reduce inflammation and promote healing. In this clinical trial, MSV-allo® is being tested to see if it can help patients with lupus nephritis, a condition where the kidneys become inflamed due to lupus. The goal is to determine if MSV-allo® can help patients achieve either a complete or partial remission of their symptoms.

Msv-Allo

What is already known about the treatment

MSV-ALLO – This medication is administered through intravenous infusion, allowing the therapeutic cells to enter the bloodstream directly. Currently, MSV-ALLO is under investigation in clinical trials and is not yet widely available in medical practice. It is primarily being studied for its potential to treat lupus nephritis, a kidney condition associated with lupus. The medication works by utilizing mesenchymal cells, which are believed to help modulate the immune system and reduce inflammation at the molecular level. MSV-ALLO falls under the pharmacological classification of cell-based therapies, specifically focusing on immune modulation.

Investigated diseases

Lupus Nephritis – Lupus Nephritis is a kidney disorder that occurs as a complication of systemic lupus erythematosus (SLE), an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. The disease can cause symptoms such as swelling, high blood pressure, and changes in urine, including blood or protein. Over time, the inflammation can impair kidney function, potentially leading to chronic kidney disease. The progression of Lupus Nephritis can vary, with periods of flare-ups and remission. Monitoring and managing the condition is crucial to prevent further kidney damage.