AuthorisedPhase II and Phase III (Integrated)Interventional

SCARR : « Allogenic Umbilical Cord Mesenchymal Stromal Cells for the treatment of chronic renal (cABMR) graft rejection »

This study, called SCARR, is investigating a new treatment for chronic kidney transplant rejection in adults. After a kidney transplant, sometimes the body's immune system starts to reject the new kidney. This study is for people experiencing a specific type of rejection that doctors call 'chronic humoral rejection', which has not improved with standard treatments. The new treatment uses special cells, called mesenchymal stromal cells, taken from umbilical cords. Researchers want to see if these cells can help the transplanted kidney function better and prevent the need for dialysis. They will measure changes in kidney function over two years and also monitor safety.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

18 Feb 2025

Adult Patients kidney transplant recipients who have developed chronic humoral rejection diagnosed through a kidney biopsy (Banff 2017 Classification)resistant to conventional treatment (3 injections at one-month intervals of 2g/kg of IVIG)

What is this study about?

When someone receives a kidney transplant, their own body's defence system, called the immune system, sometimes sees the new kidney as foreign. This can lead to the body trying to attack and damage the transplanted kidney, which is known as rejection. There are different types of rejection.

This particular study is focusing on a type of rejection called 'chronic humoral rejection' which is a long-term problem that affects the blood vessels in the kidney. This type of rejection is tricky to treat, and sometimes the usual medicines don’t work well enough. In this study, doctors are trying a new approach using special cells called mesenchymal stromal cells. These cells come from umbilical cords, which are usually discarded after a baby is born. Researchers believe these cells might help to calm the immune system and protect the transplanted kidney.

The main goal of this study is to see if these umbilical cord cells can improve how well the transplanted kidney works over two years. They will be measuring the kidney's filtering ability. The study will also carefully check if the treatment is safe and look at other things like how the kidney tissue changes, and if people need dialysis less often. This research is important because it could offer a new way to help people with kidney transplants keep their new kidney working for longer.

Key takeaways

Tests a new cell therapy for kidney transplant rejection.
Uses special cells from umbilical cords.
Aims to improve kidney function and prevent dialysis.
For adults with kidney transplant rejection not responding to standard treatment.
Participation involves regular tests and monitoring over two years.
Could offer a new option for managing chronic rejection.

Who may be eligible?

This study is for adults who have received a kidney transplant. You must be over 18 years old to take part. The study is open to both men and women.

To be considered, you must have been diagnosed with a specific type of kidney rejection called 'chronic humoral rejection'. This diagnosis needs to be confirmed by a kidney biopsy, which is a small sample of kidney tissue taken for examination. Importantly, your rejection must not have gotten better after receiving standard treatment, which involves three sessions of a specific medication given once a month.

If you meet these general conditions, the study team will carry out further checks to make sure this study 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.

Are you an adult (18 years or older) with a kidney transplant?
Have you been diagnosed with 'chronic humoral rejection' confirmed by a kidney biopsy?
Has your rejection not improved after a specific standard treatment (three doses of IVIG)?
Are you willing and able to attend regular appointments for two years?

Answer every question to see your result.

What does participation involve?

If you join the study, you would receive the study treatment, which is either a saline solution (salt water) or the special umbilical cord cells. This would be given as an infusion, meaning it goes directly into your bloodstream, and you would be carefully monitored for several hours immediately afterwards.

You would have regular appointments over a period of two years (24 months). These appointments would involve various tests to check your kidney function, such as blood tests to measure your estimated glomerular filtration rate (eGFR) at different times (e.g., at the start, and then at 1, 2, 6, 12, 18, and 24 months). Other tests might include checking your urine for protein, taking blood samples to look at your immune system, and possibly another kidney biopsy at 6 months to see changes in the kidney tissue. The total duration of your active participation in the study would be two years.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new cell therapy helps your transplanted kidney work better and keeps you from needing dialysis. However, there's no guarantee it will work for everyone, as this is a research study. Like all medical treatments, there could be risks involved, such as side effects from the cell infusion, which will be closely monitored. You will be told about all known risks before you decide to join. 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 medical care.

Locations (1)

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

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Unverified
France

Common questions

What are mesenchymal stromal cells (MSCs)?

These are special cells, similar to stem cells, taken from umbilical cords. They are thought to help calm the immune system and support healing.

What is 'chronic humoral rejection'?

This is a type of long-term rejection where your body's immune system attacks the blood vessels in your transplanted kidney, causing damage over time.

Why is the study measuring kidney function (eGFR)?

eGFR is a way to estimate how well your kidneys are filtering waste from your blood. An improvement in eGFR means your kidney is working better.

Will I need a kidney biopsy if I join?

Yes, you would have already had one for diagnosis, and there may be another one at 6 months to check for changes in your kidney tissue.

How long will I be in the study?

The study will last for two years (24 months) with regular check-ups and tests.

How to find out more

Official trial record

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