AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

Allogeneic adipose tissue-derived Mesenchymal stromal cells for the treatment of chronic-active antibody mediated rejection in Kidney transplant recipients

This research is looking at a new way to treat a type of kidney transplant rejection called 'chronic active antibody mediated rejection'. This is when the body's immune system attacks the transplanted kidney. The study uses special cells, called mesenchymal stromal cells (MSCs), which are taken from body fat. We want to find out if giving these cells is safe for patients and if they can help the kidney work better, or even prevent it from failing. This is an early-stage study, meaning it's one of the first times this treatment is being tested in humans. We'll be checking how well patients tolerate the treatment and how their kidney health changes over time.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Region Midtjylland

Enrolment target

Start

09 Mar 2026

Chronic active antibody mediated rejection

What is this study about?

When someone receives a kidney transplant, their own body's defence system, called the immune system, can sometimes mistake the new kidney for something harmful. This can lead to the body 'rejecting' the kidney. One type of rejection is called 'chronic active antibody mediated rejection', which means the rejection is ongoing and caused by specific immune proteins called antibodies.

This study is exploring a new treatment idea using special cells known as mesenchymal stromal cells, or MSCs. These cells are taken from fat tissue. The idea is that these MSCs might help calm down the immune system and protect the transplanted kidney from damage. Because this is a very new treatment approach, this study is focusing on two main things: first, checking if it's safe for people to receive these MSCs, and second, seeing if there are any early signs that it could help improve the kidney's health or prevent it from failing. This is a crucial early step to understand if this treatment could be helpful in the future.

The study is designed to carefully watch how people respond to the MSCs. We'll be looking at things like how many people can safely receive the treatment, how many don't have bad side effects from the infusion itself, and importantly, how many avoid serious problems like their kidney failing or needing to be removed. We'll also be checking how well the kidneys are working before and after the treatment, using blood tests, scans, and sometimes kidney samples to see if there are any positive changes.

Key takeaways

This study evaluates a new treatment for kidney transplant rejection using cells from body fat.
It's an early-stage study, focused on safety and initial signs of effectiveness.
The treatment involves a special cell infusion, followed by regular check-ups.
Participants must have 'chronic active antibody mediated rejection' and be over 18.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with 'chronic active antibody mediated rejection' of your transplanted kidney. This specific diagnosis is key for joining this research, as the study is directly testing a treatment for this condition.

Other specific health conditions, medications you are taking, or previous medical treatments might affect whether you can participate. These details would be carefully reviewed by the study doctors to make sure the study would be safe and appropriate 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?
Have you had a kidney transplant?
Have you been diagnosed with 'chronic active antibody mediated rejection' of your kidney?
Are you able to attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive an infusion of mesenchymal stromal cells. This is like getting medicine directly into your bloodstream through a drip. The doctors would carefully monitor you during and after this infusion to check for any immediate reactions. Over a period of time, you would have several scheduled visits to the hospital or clinic. During these visits, the study team would perform various assessments to see how you are doing and how your kidney is responding. These might include blood tests, urine tests, perhaps some scans, and potentially further kidney biopsies. The total duration of your participation, including follow-up appointments, would be explained by the study team, but it would involve a commitment to regular check-ups over several months to gauge the long-term effects of the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, a potential benefit is that the treatment could help your transplanted kidney and improve its function, but this is not guaranteed, as it is an early-stage study. Risks might include discomfort or side effects from the cell infusion itself, or potential unforeseen reactions to the new treatment. The research team will carefully monitor you for any problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What are mesenchymal stromal cells (MSCs)?

MSCs are special cells found in your body, for example, in fat tissue. They are thought to have properties that could help calm the immune system and aid in repair.

What does 'chronic active antibody mediated rejection' mean?

This is a type of ongoing rejection where your body's immune system, specifically antibodies, attacks your transplanted kidney, causing it damage over time.

Is this a new treatment?

Yes, this is an early-stage study (Phase I and Phase II), meaning it's one of the first times this specific treatment using MSCs is being given to people for this condition. We are mainly checking its safety and early effects.

Will this treatment definitely cure my kidney rejection?

No, because this is an early-stage study, we cannot guarantee a cure. The main goals are to check if the treatment is safe and to see if there are any promising signs it could help.

Do I have to pay to be in the study?

No, your participation in the study, including the treatment and all study-related visits and tests, would be covered by the research. You would not have to pay for these.