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Study on the Safety of Decidua Stromal Cells for Patients with Steroid-Resistant Severe Acute Graft vs Host Disease

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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 Graft versus Host Disease (GvHD), which can occur after a patient receives a stem cell transplant from a donor. The trial is specifically looking at patients who have a severe form of this condition that does not respond to standard steroid treatments. The treatment being tested in this study involves the use of a special type of cell therapy called Decidua Stromal Cells (DSC), which are derived from the placenta and expanded outside the body. Three different formulations of this treatment, known as DSC 1.0, DSC 1.4, and DSC 2.0, will be compared to the best available treatment options currently used for this condition.

The purpose of the study is to assess the safety and effectiveness of these cell therapies in treating severe acute GvHD. Participants in the study will receive the treatment through an infusion, which means the solution is administered directly into the bloodstream. The study will monitor how well patients respond to the treatment over a period of time, specifically looking at their response at 28 days and 56 days after starting the treatment. The study will also track any side effects or complications that may arise during the treatment period.

Throughout the study, researchers will evaluate the overall survival of patients, which refers to the time from the start of the treatment until death from any cause. They will also look at the occurrence of infections or other complications related to the transplant. The study aims to provide valuable information on whether these new cell therapies can offer a safe and effective treatment option for patients with severe acute GvHD who do not respond to standard steroid treatments.

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, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the trial.
Eligibility includes being 18 years or older and having undergone a specific type of stem cell transplant. The patient must have a clinical diagnosis of acute Graft vs Host Disease (GvHD) that is resistant to steroid treatment.
Step 2
Randomization and treatment assignment
The patient is randomly assigned to one of two treatment groups: one receiving Decidua Stromal Cells (DSC) and the other receiving the best available treatment (BAT).
The purpose is to compare the safety and effectiveness of DSC against BAT in treating steroid-resistant acute GvHD.
Step 3
Treatment administration
For those in the DSC group, the treatment involves intravenous administration of a solution for infusion. The specific products used are Decidua Stromal Cell 2.0, Decidua Stromal Cell 1.0, or Decidua Stromal Cell 1.4.
The frequency and duration of the treatment are determined by the study protocol and the patient's response to the treatment.
Step 4
Monitoring and assessment
Throughout the trial, the patient's response to the treatment is closely monitored. This includes documenting any adverse events (AEs) or serious adverse events (SAEs) and assessing their relation to the treatment.
The primary goal is to evaluate the safety and tolerability of the treatment, as well as the overall response rate at 56 days.
Step 5
Evaluation of outcomes
The study measures various outcomes, including the proportion of patients achieving a complete or partial response by day 28 and maintaining it by day 56.
Secondary outcomes include overall survival, non-relapse mortality, and the occurrence of infections or other complications related to the transplant.
Step 6
Completion of the trial
The trial is expected to continue until December 31, 2030. The patient's participation may end earlier depending on their response to the treatment and any adverse effects experienced.
Upon completion, the data collected will contribute to understanding the safety and effectiveness of DSC in treating steroid-resistant acute GvHD.

Who can join the trial?

8 criteria

The patient must sign a form to show they understand and agree to join the study.
The patient can be a man or a woman and must be 18 years old or older.
The patient must have had a **hematopoietic stem cell transplant (HSCT)**. This is a procedure where a patient receives blood-forming stem cells from a donor. The donor can be a relative or someone unrelated, and the stem cells can come from bone marrow, blood, or umbilical cord blood.
The patient must have been diagnosed with **acute Graft vs Host Disease (aGvHD)**, which is a condition that can occur after a stem cell transplant. The disease should be Grades II to IV, which means it is moderate to severe, and it requires treatment with medicines that suppress the immune system.
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The patient must have a confirmed diagnosis of **steroid refractory aGvHD**. This means the disease does not improve with high doses of steroids, which are medicines used to reduce inflammation. The patient must meet one of the following conditions:
- The disease gets worse after at least 3 days of treatment with high-dose steroids, with or without other medicines called **calcineurin inhibitors (CNI)**.
- The disease does not show at least a partial improvement after 5-7 days of treatment with high-dose steroids, with or without CNI.
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  The patient cannot reduce the steroid dose successfully, which means:
  - The steroid dose needs to be increased again to a high level.
  - The patient cannot lower the steroid dose to a certain level for at least 7 days.

Who cannot join the trial?

4 criteria

Patients with a condition called Graft vs Host Disease cannot participate. This is a situation where the immune cells from a transplant attack the body of the person who received the transplant.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who do not meet the gender requirements cannot participate. The trial is open to both males and females.
Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Verified sites

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Oslo Universitetssykehus HF
Oslo, Norway
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Region Skane Skanes Universitetssjukhus
Lund, Sweden
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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Decidua Stromal Cells (DSC)
are a type of cell therapy used in this clinical trial. These cells are derived from the decidua, which is the lining of the uterus during pregnancy. In this trial, they are being tested for their ability to treat patients with severe acute Graft-versus-Host Disease (GvHD) who have not responded to steroid treatments. The goal is to see if these cells can help reduce the symptoms of GvHD and improve the patient's condition.
Best Available Treatment (BAT)
refers to the standard treatments currently used for managing severe acute GvHD in patients who do not respond to steroids. This can include a variety of medications and therapies that are considered effective based on current medical practice. The trial compares the effectiveness and safety of DSC against these existing treatments to determine which is more beneficial for patients.

Allogeneic Placenta-Derived Decidual Stromal Cells, Ex-Vivo Expanded

What is already known about the treatment

Decidua Stromal Cells (DSC) – This medication is administered through infusion and is currently being studied in clinical trials for its potential use in treating steroid-resistant severe acute Graft vs Host Disease (GvHD) following allogeneic hematopoietic stem cell transplantation. The main therapeutic indication is to improve the response rate in patients who do not respond to standard steroid treatments. At the molecular level, DSCs are believed to modulate the immune response, potentially reducing inflammation and tissue damage associated with GvHD. They are classified under cell-based therapies, which are a part of regenerative medicine.

Investigated diseases

Graft vs Host Disease – This condition occurs when donor cells from a transplant attack the recipient's body. It is a common complication following a bone marrow or stem cell transplant. The disease can affect various parts of the body, including the skin, liver, and digestive tract. Symptoms may include skin rashes, jaundice, and gastrointestinal issues such as diarrhea. The severity of the disease can vary, with some cases being mild and others more severe. Over time, it can lead to chronic issues if not managed properly.