Recruiting

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

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of stem cells
An infusion of mesenchymal stem cells, which are specialized cells derived from fat tissue, is administered through an intravenous line (a tube inserted into a vein).
The product used is a suspension for infusion containing allogeneic adipose-derived mesenchymal stem cells.
Step 2
Monitoring and assessment
The kidney function is assessed by measuring the eGFR, which is a calculation used to check how well the kidneys are filtering blood.
The condition of the kidney is evaluated through biopsy (taking a small tissue sample), imaging (pictures of the inside of the body), and urinary findings (testing the urine).
The immune response is monitored by checking for DSAs (donor-specific antibodies, which are proteins that can attack the transplanted organ), immune cells, and inflammation markers.
The presence of any opportunistic infections (infections that occur more easily when the immune system is affected) is assessed.
Any adverse events (unwanted or unexpected medical occurrences) are recorded to ensure safety.

Who can join the trial?

9 criteria

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 trial?

9 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED

What is already known about the treatment

MSC, adipose tissue - This treatment is a liquid suspension that is delivered directly into a person's vein through an intravenous infusion. These specialized cells, derived from fat tissue, are currently being studied in clinical trials for their potential to help treat immune system issues, specifically for patients whose bodies are attacking a transplanted kidney. The cells work by communicating with the immune system to reduce harmful inflammation and protect organ tissue from damage. This type of therapy is classified as a cellular medicinal product used for its ability to regulate and balance the body's immune response.

Investigated diseases

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.