A multicenter, open-label, randomized, phase II clinical trial comparing safety and durable overall response rate (DOR) at 56 days in patients with steroid resistant severe acute GvHD after allogeneic hematopoietic stem cell transplantation treated with decidua stromal cells (DSC) or best available treatment (BAT)
This study is for adults who have severe Graft-versus-Host Disease (GvHD) after a stem cell transplant and whose condition hasn't improved with steroid treatment. Researchers want to see how safe and effective a new cell therapy, called Decidua Stromal Cell (DSC), is compared to their usual treatment (Best Available Treatment, BAT). They will check for any side effects and how long patients' conditions improve after treatment. The study also explores how this new treatment affects survival, infections, and other transplant-related issues over time. This is a Phase II study, meaning it's still in the early stages of testing for safety and effectiveness.
At a glance
What is this study about?
This study is looking into a new treatment for a serious condition called Graft-versus-Host Disease, or GvHD. GvHD can happen after a stem cell transplant when the donated cells start to attack the patient's body. This can be very severe, and sometimes steroid medications don't help enough. This new treatment uses special cells called Decidua Stromal Cells (DSC).
If you take part in this study, you would be randomly assigned to either receive this new cell treatment or the best usual care that doctors would normally give for your condition. The main things the doctors want to find out are how safe the new treatment is (looking at any side effects) and if it helps patients get better and stay better for at least 56 days. They will compare these results between the two groups of patients.
Beyond safety and the main improvement, the study will also look at other important things. This includes how many patients improve, how long patients live, how often other problems like infections happen, and general impacts on health and well-being. This is an important step to see if this new cell therapy could be a better option for people with severe GvHD.
Key takeaways
- This study is for adults with severe GvHD after a stem cell transplant.
- It focuses on GvHD that hasn't improved with steroid treatment.
- It compares a new cell treatment (DSC) with standard care.
- The main goals are to check treatment safety and how long patients' conditions improve.
- You would be randomly assigned to one of the two treatment groups.
- Participation involves regular check-ups and monitoring.
Who may be eligible?
This study is for adults, meaning you must be 18 years old or older to take part. Both men and women can join the study.
The main requirement is that you have severe Graft-versus-Host Disease (GvHD) that developed suddenly after an allogeneic hematopoietic stem cell transplant. This means your GvHD started because of cells from a donor, and it's considered serious.
Crucially, your GvHD must also be 'steroid resistant'. This means that treatment with steroids hasn't worked well enough to control your GvHD. If your doctors are looking for other treatment options because steroids haven't helped, this study might be an option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have severe GvHD that started after an allogeneic (donor) stem cell transplant?
- Has your GvHD not responded well to steroid treatment?
- Are you able to attend regular appointments and follow study instructions?
What does participation involve?
If you decide to take part, you would be randomly assigned to one of two groups: one receiving the new Decidua Stromal Cell treatment, and the other receiving the best available standard treatment. You would have regular appointments and tests to check your health, see how your GvHD is responding, and monitor for any side effects. These tests might include blood samples, physical examinations, and other checks deemed necessary by the study doctors. The study would closely follow your progress for at least 56 days after treatment, though some monitoring may continue for longer to understand the long-term effects. The exact number of visits, tests, and the total duration of your participation would be explained in detail by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedSweden
- —UnverifiedNorway
- —UnverifiedDenmark
Common questions
What is GvHD?
GvHD stands for Graft-versus-Host Disease. It's a complication that can happen after a stem cell transplant, where the donated cells (the 'graft') attack the patient's body (the 'host').
What does 'steroid resistant' mean?
It means that your GvHD hasn't responded well to treatment with steroids, and doctors are looking for other options to help manage your condition.
What are Decidua Stromal Cells (DSC)?
These are special cells being investigated as a new type of treatment. This study is testing if they are safe and effective for GvHD.
What does 'randomised' mean in a study?
It means patients are put into different treatment groups by chance, like flipping a coin. This helps make sure the study results are fair and reliable.
How long will the study follow me?
The study will closely track your condition for at least 56 days after your treatment, with some longer-term monitoring also taking place.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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