A study of allogeneic adipose-derived mesenchymal stem cells for the treatment of chronic active antibody-mediated rejection in kidney transplant recipients

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What is this study about?

This study focuses on individuals who have received a kidney transplant and are experiencing Chronic active antibody mediated rejection. This condition occurs when the body’s immune system produces antibodies that attack the transplanted organ, potentially leading to long-term damage. The research aims to evaluate the safety and effectiveness of using allogeneic adipose-derived mesenchymal stem cells, which are specialized cells taken from fat tissue of a donor and grown in a laboratory. These cells are used because of their ability to help regulate the immune system and protect organs.

The treatment involves the administration of MSC through an intravenous infusion, which is a process where the cell suspension is delivered directly into a vein. During the study, the focus is on monitoring how the body responds to these cells and observing any changes in kidney function or immune activity. Participants will be monitored to ensure the procedure is safe and to see if the treatment helps prevent further damage to the transplanted kidney.

Who Can Join the Study?

You must have a confirmed diagnosis of chronic active antibody mediated rejection, which is a condition where your body’s immune system attacks the transplanted kidney over a long period.
A biopsy, which is a procedure where a small piece of tissue is removed to be examined under a microscope, must show signs of long-term tissue damage.
There must be evidence that antibodies, which are proteins in your blood that help the immune system fight germs, are currently or recently attacking the lining of your blood vessels.
Blood tests must show the presence of donor-specific antibodies (DSA), which are specific proteins that recognize and attack the transplanted organ.
You must be between 18 and 75 years of age.
You must have received a kidney transplant at least 6 months before joining this study.
Your estimated Glomerular Filtration Rate (eGFR), which is a measure of how well your kidneys are filtering waste from your blood, must be greater than 20 ml/min.
You must provide written, informed consent, which means you have read and signed a document agreeing to participate after understanding the study details.
If you are a female who could become pregnant, you must not be pregnant or breastfeeding, and you must use effective contraception, which are methods used to prevent pregnancy.

Who Cannot Join the Study?

You have had a transplant of more than one organ, unless it was a kidney and pancreas at the same time, or if you have had previous kidney transplants or cell transplants (such as bone marrow or islet cell transplants).
You have had acute rejection, which means your body has recently attacked your transplanted organ, that was confirmed by a biopsy (a medical procedure where a small piece of tissue is removed for testing) within the last 4 weeks.
You have used any treatments for antibody-mediated rejection (ABMR) or T-cell mediated rejection (TCMR)—which are different ways the immune system attacks a transplant—within the last 3 months, other than steroids.
You are currently using dialysis (a machine that filters your blood because your kidneys cannot) or you are expected to start dialysis within the next 3 months.
You have an active bacterial or viral infection, such as CMV, HIV, hepatitis B or C, or fungal infections, though a simple bladder infection is allowed.
You have a psychiatric disorder (a mental health condition) or an addiction that would make it difficult for you to fully understand and agree to all parts of the study.
You are currently taking any investigational drug (a medicine that is still being tested and is not yet widely available).
You have had malignancy, which is another word for cancer, including lymphoproliferative disease (a type of cancer involving the immune system), within the last 2 years, unless it was a specific type of skin cancer that has been fully treated.
You are unwilling or unable to follow the specific rules and steps required by the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.02.2026

Trial locations

Investigated drugs:

ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED

Mesenchymal stem cells from fat tissue are a type of cell therapy used to see if they can help protect the kidneys and adjust the immune system in people who have received a kidney transplant and are experiencing a specific type of immune rejection.

Investigated diseases:

Kidney transplant rejection

Chronic active antibody mediated rejection – This condition occurs when the body’s immune system produces antibodies that mistakenly attack a transplanted kidney. These antibodies bind to the cells of the new organ, causing ongoing inflammation and damage to the blood vessels. Over time, this process leads to scarring and thickening of the vessel walls within the kidney. As the damage progresses, the organ’s ability to filter waste from the blood gradually decreases. This cycle of immune attack and tissue repair results in permanent structural changes to the kidney tissue.

Trial ID:

2024-510723-18-00

Trial Phase:

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

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A study of allogeneic adipose-derived mesenchymal stem cells for the treatment of chronic active antibody-mediated rejection in kidney transplant recipients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?