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Study on Mesenchymal Stromal Cells (MC0518) for Treating Steroid-Resistant Acute Graft Versus Host Disease in Adults and Adolescents

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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 a condition known as steroid-refractory acute graft-versus-host disease (SR aGvHD). This condition can occur in patients who have undergone a stem cell transplant and have not responded to steroid treatments. The trial will test a new treatment using mesenchymal stromal cells, which are special cells grown outside the body, known by the code name MC0518. These cells will be compared to the best available therapy currently used for treating SR aGvHD.

The purpose of the study is to determine if MC0518 is more effective than the current best available treatments in improving the condition of patients with SR aGvHD. Participants in the study will receive either the MC0518 treatment or the best available therapy. The study will monitor the participants' response to the treatment over a period of time, checking for improvements in their condition and overall survival.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their health. The study aims to provide valuable information on the safety and effectiveness of MC0518 in treating SR aGvHD, potentially offering a new option for patients who do not respond to standard steroid treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to receive either the experimental treatment with mesenchymal stromal cells or the best available therapy.

    The study is designed to compare the effectiveness of these treatments in patients who have experienced a specific type of immune response after a stem cell transplant.

  2. Step 2

    Treatment administration

    The patient receives the assigned treatment. If receiving mesenchymal stromal cells, the administration is done intravenously.

    If assigned to the best available therapy, the treatment may include medications such as mycophenolate mofetil, mycophenolic acid, or everolimus, which are taken orally.

  3. Step 3

    Monitoring and follow-up

    The patient's response to the treatment is monitored at various intervals, including Day 28, Day 60, Day 100, and Day 180.

    The primary goal is to assess the overall response, which includes complete or partial improvement of symptoms.

  4. Step 4

    Evaluation of outcomes

    The study evaluates the patient's overall survival and response to treatment over a period of up to 24 months.

    Secondary outcomes include the time to response, duration of response, and any adverse events experienced during the trial.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 2027, with final assessments and data collection completed by this time.

    The results will contribute to understanding the effectiveness and safety of the treatments for patients with this condition.

Who can join the trial?

8 criteria

  • The patient must have had a previous **allogeneic HSCT**. This is a type of stem cell transplant from a donor, used for certain diseases.
  • The patient must have been diagnosed with **Grade II to IV aGvHD**. This is a condition that can occur after a stem cell transplant.
  • The patient must have experienced failure of previous first-line treatment for aGvHD, known as **steroid refractory aGvHD**. This means the condition did not improve with initial treatment.
  • The patient must be at least 12 years old and weigh at least 15 kg (about 33 pounds).
  • The patient must have an estimated life expectancy of more than 28 days.
  • If the patient is a female who can have children, she must agree to use a highly effective birth control method during the trial.
  • If the patient is a fertile male, he must agree to either abstain from sex or use a condom during sexual activity. If his partner can have children, she must also use an additional effective birth control method.
  • The patient or their parent/legal guardian must have read, understood, and signed the informed consent form, which explains the trial and its requirements.

Who cannot join the trial?

10 criteria

  • Patients who have not responded to treatment with **steroids**. Steroids are medications often used to reduce inflammation and help with certain medical conditions.
  • Patients who have not been diagnosed with **Acute Graft versus Host Disease (aGvHD)**. This is a condition that can occur after a bone marrow transplant, where the donated cells attack the recipient's body.
  • Patients who are not within the specified age range for the study. The study includes adults and adolescents.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have another medical condition that might interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who have a serious infection that is not well controlled.
  • Patients who have a history of certain types of cancer that might affect the study results.
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Investigated drugs

  • MC0518

    is a treatment being tested in this trial. It consists of mesenchymal stromal cells, which are a type of cell that can help reduce inflammation and support healing. This therapy is being studied to see if it can improve outcomes for patients who have not responded to steroid treatments for acute graft-versus-host disease, a condition that can occur after a stem cell transplant.

  • Best Available Therapy (BAT)

    refers to the standard treatments currently used for managing acute graft-versus-host disease when steroids are not effective. This can include a variety of medications and approaches that are considered the most effective options available based on current medical knowledge and practice. The trial is comparing the new treatment, MC0518, to these existing therapies to see which is more effective.

What is already known about the treatment

Mesenchymal Stromal Cells MC0518 – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating steroid-refractory acute graft versus host disease (aGvHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation. The main therapeutic indication is to improve overall response rates and survival in patients with this condition. At the molecular level, mesenchymal stromal cells are believed to modulate immune responses and promote tissue repair by interacting with various immune cells. This medication falls under the pharmacological classification of cell-based therapies.

Investigated diseases

Steroid Refractory Acute Graft Versus Host Disease – This condition occurs when the body of a transplant recipient attacks the donated cells, tissues, or organs, and does not respond to standard steroid treatments. It typically arises after a bone marrow or stem cell transplant. The disease primarily affects the skin, liver, and gastrointestinal tract, leading to symptoms such as rash, jaundice, and diarrhea. The progression of the disease can vary, with some patients experiencing mild symptoms while others may have severe organ involvement. The condition is considered acute when it develops within the first 100 days post-transplant. Management of this disease focuses on controlling the immune response to prevent further damage to the recipient's body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505737-26-00Protocol codeMC-MSC.1/aGvHDEstimated enrolment198 patientsSponsorMedac Gesellschaft fuer klinische Spezialprapaerate mbH

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