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Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease

This program is for people suffering from a severe bowel condition called acute Graft-versus-Host Disease (aGvHD) in the gut. This condition can happen after a stem cell transplant. For these patients, standard steroid treatments haven't worked, and they have very few other options. The study drug, MaaT013, is still being developed and isn't approved yet for general use. However, because these patients are so unwell, this early access program allows them to try MaaT013. The aim is to help those with life-threatening gi-aGvHD that hasn't improved with other medicines. Previous studies have looked at its safety and how well it works, and a larger study is planned for the future. This program offers a potential new path for those with nowhere else to turn.

At a glance

What is this study about?

This early access program is for a very serious condition called acute Graft-versus-Host Disease (aGvHD) that affects the gut. aGvHD can happen to people who have had a special type of transplant called a stem cell transplant, where new, healthy cells are given to them. Sometimes, these new cells see the patient's body as 'foreign' and start to attack it. When this attack happens in the gut, it can cause severe problems like bad diarrhoea and stomach pain.

The most common treatment for aGvHD is with medicines called steroids. However, for some people, these steroids don't work, or they stop working. This is called 'steroid-refractory' aGvHD. For these patients, there are very few other treatment options, and the condition can be life-threatening. This program offers a new, experimental treatment called MaaT013, which is still being tested and hasn't been officially approved for sale yet.

MaaT013 is a special type of medicine that uses healthy gut bacteria, called 'pooled allogeneic fecal microbiota.' It's hoped that by introducing these healthy bacteria, it can help calm down the gut and reduce the severe symptoms of aGvHD when other treatments have failed. This early access program is a way to provide this experimental treatment to patients who desperately need it, while larger studies are still underway to fully understand how well it works and if it's safe for everyone. It's an important step for patients with very limited choices.

Key takeaways

  • This program is for a serious gut condition (aGvHD) after a stem cell transplant.
  • It's for people whose condition hasn't improved with standard steroid treatments.
  • MaaT013 is an unapproved, experimental treatment using healthy gut bacteria.
  • This is an 'early access' program for patients with very limited treatment options.
  • Your health will be closely monitored if you participate.

Who may be eligible?

This program is for adults aged 18 or older. You might be able to take part if you have severe acute Graft-versus-Host Disease (aGvHD) affecting your gut, which hasn't gotten better with standard steroid treatment and other medicines. This also includes people who can't reduce their steroid dose because their condition flares up again.

However, there are reasons why you might not be able to join. For example, if you have an active infection that isn't under control, or if your original cancer has come back and needs urgent treatment. You also can't take part if you have certain existing gut problems like a blocked bowel, or if you are pregnant or breastfeeding. Your medical team will carefully check all these points to see if this program is right 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.

  1. Are you 18 years old or older?
  2. Do you have severe gut aGvHD that hasn't responded to steroids and other medicines?
  3. Can you not reduce your steroid dose because your aGvHD gets worse?
  4. Do you currently have a severe, uncontrolled infection?
  5. Are you currently pregnant or breastfeeding?
  6. Do you have existing severe bowel problems like a blockage?
Answer every question to see your result.

What does participation involve?

If you take part in this program, you will receive the MaaT013 treatment. The specifics of how often you will be given the treatment and for how long would be explained in detail by your medical team. You will have regular check-ups, which include appointments and tests, to see how you are responding to the treatment and to monitor your health. These check-ups are important to track any changes and ensure your safety. The total length of your participation would depend on how your condition responds and the program's specific rules, all of which will be discussed with you by your doctor.

Potential risks and benefits

The potential benefit of taking part in this early access program is the chance to receive a new treatment for a very serious gut condition (aGvHD) that has not responded to other medicines. This could offer hope for patients with limited options. However, because MaaT013 is still being developed, all its potential side effects may not be fully known. There could be risks associated with the treatment, and it might not work for everyone. You have the right to withdraw from the program at any time, for any reason, without it affecting your future medical care.

Locations (46)

  • University Clinic - State Hospital of Innsbruck
    Verified postcode
    Innsbruck, Austria· Available
  • Ordensklinikum Linz Elisabethinen
    Verified postcode
    Linz, Austria· Available
  • Az Sint-Jan Brugge Av
    Verified postcode
    Bruges, Belgium· Available
  • Hub - Institut Jules Bordet
    Verified postcode
    Brussels, Belgium· Available
  • Foothills Medical Centre
    Verified postcode
    Calgary, Canada· Available
  • Chu Amiens Picardie Site Sud
    Verified postcode
    Amiens, France· Available
  • Chu Angers
    Verified postcode
    Angers, France· Available
  • Chu Besancon
    Verified postcode
    Besançon, France· Available
  • Chu Morvan
    Verified postcode
    Brest, France· Available
  • Chu de Caen
    Verified postcode
    Caen, France· Available
  • Chu Grenoble
    Verified postcode
    Grenoble, France· Available
  • Chu de Lille
    Verified postcode
    Lille, France· Available

Common questions

What is MaaT013?

MaaT013 is an experimental medicine that uses healthy gut bacteria. It's being developed to help people with a severe gut condition called aGvHD that hasn't improved with other treatments.

Is MaaT013 approved for general use?

No, MaaT013 is still in the testing phase and has not been approved for general use or marketing yet by health authorities.

What is 'steroid-refractory' aGvHD?

This means your acute Graft-versus-Host Disease in the gut hasn't gotten better, or has worsened, despite treatment with standard steroid medicines.

Can I stop the program if I want to?

Yes, you have the right to leave the program at any time, for any reason. This will not affect the medical care you receive in the future.

What type of transplant causes aGvHD?

aGvHD can happen after a stem cell transplant, where you receive blood-forming cells from another person (an 'allogeneic' transplant).

How to find out more

MaaT Pharma

Always speak to your GP or specialist before deciding to take part in a study.

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