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Study on Allogeneic Umbilical Cord Mesenchymal Stromal Cells for Treating Chronic Kidney Transplant Rejection in Adult Patients

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition known as chronic renal graft rejection, which can occur in patients who have received a kidney transplant. This condition is also referred to as chronic antibody-mediated rejection (cABMR). It happens when the body’s immune system attacks the transplanted kidney, leading to a gradual loss of kidney function. The study is exploring a new treatment using allogeneic umbilical cord mesenchymal stromal cells, which are special cells derived from umbilical cords. These cells are expanded outside the body and then used in a treatment called cell therapy. The treatment is given as a suspension for intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective these umbilical cord cells are in improving kidney function over a period of 24 months in patients with cABMR. Participants in the study will receive injections of these cells and will be monitored for changes in their kidney function. The study will also look at the safety of the cell injections and how they affect the body. Participants will have regular check-ups to assess their kidney function and overall health. The study will also compare the results with those of patients who receive a placebo, which is a substance with no active treatment.

Throughout the study, various health indicators will be measured, such as kidney function, protein levels in urine, and the presence of specific antibodies that can affect the kidney. The study aims to provide valuable information on whether this new cell therapy can help improve outcomes for patients experiencing chronic rejection of their transplanted kidney. The trial is expected to run until 2028, with the goal of finding a more effective treatment for this challenging condition.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The patient undergoes an initial assessment to confirm eligibility for the trial. This includes verifying age, kidney transplant history, and current health status.
A kidney biopsy is reviewed to confirm chronic humoral rejection, and the presence of donor-specific antibodies is checked.
Step 2
Informed consent
The patient is provided with detailed information about the trial and must sign an informed consent form to participate.
Step 3
Baseline measurements
Baseline measurements are taken, including estimated glomerular filtration rate (eGFR), proteinuria levels, and other relevant health indicators.
Step 4
Treatment administration
The patient receives an intravenous infusion of allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UC-MSC).
The infusion is administered as a suspension for IV infusion, using thawed and washed cells.
Step 5
Post-infusion monitoring
The patient is monitored for four hours after the infusion to ensure safety. This includes checking oxygen saturation, blood pressure, and other vital signs.
Step 6
Follow-up consultations
The patient attends regular follow-up consultations to monitor renal function and overall health.
Measurements of eGFR and proteinuria are taken at specified intervals: Day 0, Month 1, Month 2, Month 6, Month 12, Month 18, and Month 24.
Step 7
Secondary assessments
Additional assessments include checking for donor-specific antibodies, quantifying fibrosis, and evaluating immune cell profiles at various points during the trial.
Step 8
Final evaluation
At the end of the 24-month period, a final evaluation of renal function and overall health is conducted to assess the effectiveness of the treatment.

Who can join the trial?

11 criteria

Must be a man or woman aged 18 years or older.
Must have had a kidney transplant for at least 1 year but less than 10 years.
Must have chronic humoral rejection diagnosed through a kidney biopsy, according to the Banff 2017 classification, within the last 6 months. This means the body is rejecting the kidney, and it has been confirmed by a specific test.
Must have donor-specific anti-HLA antibodies with a measurement (MFI) of less than 20,000. These are proteins in the blood that can attack the transplanted kidney.
Must not have responded to 3 monthly courses of a treatment called IV-IG (2 grams per kilogram). This means the usual treatment did not work.
Must have an eGFR (a measure of kidney function) greater than 30 milliliters per minute.
Must have proteinuria greater than 1 gram per 24 hours or a proteinuria/creatininuria ratio greater than 150 milligrams per millimole. This means there is a high level of protein in the urine.
Must be able to attend follow-up consultations, meaning the patient can come back for check-ups.
Must have signed an informed consent, which means the patient agrees to participate after understanding the study details.
Must be affiliated with a social security system, meaning the patient has some form of health insurance or coverage.
Must be able to understand and follow the study protocol, meaning the patient can comprehend and adhere to the study requirements.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with **chronic humoral rejection**. This is a condition where the body's immune system attacks the transplanted kidney.
Patients who have not undergone a **kidney biopsy**. This is a procedure where a small piece of kidney tissue is removed to check for disease.
Patients who have not received **conventional treatment**. This refers to the standard treatment given, which in this case is 3 injections of a medication called **IVIG** at one-month intervals.
Patients who are not adults. The study is only for adult patients.
Patients who are not kidney transplant recipients. The study is specifically for those who have received a kidney transplant.
Patients who are not resistant to the conventional treatment mentioned above. This means the treatment did not work for them.

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Hopital Beaujon
Clichy, France

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Investigated drugs

Allogeneic Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) are being studied for their potential to improve kidney function in patients experiencing chronic rejection of a transplanted kidney. These cells are derived from the umbilical cord and are believed to have properties that can help reduce inflammation and promote healing in the body. In this trial, the UC-MSCs are injected into patients to assess their effectiveness in treating chronic kidney transplant rejection over a period of 24 months.

ALLOGENEIC UMBILICAL CORD TISSUE-DERIVED MESENCHYMAL STROMAL CELLS EX VIVO EXPANDED

What is already known about the treatment

Allogeneic Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) – This medication is administered through injections and is currently being studied in clinical trials for its potential to treat chronic humoral rejection in kidney transplant recipients. The main therapeutic indication is for adult patients who have developed chronic rejection of a kidney transplant, which is resistant to conventional treatments. At the molecular level, UC-MSCs are believed to modulate the immune response, potentially reducing inflammation and promoting tissue repair. They are classified as a type of cell therapy, specifically using stem cells derived from umbilical cord tissue.

Investigated diseases

Chronic Antibody-Mediated Rejection – This condition occurs in kidney transplant recipients when the immune system produces antibodies that attack the transplanted kidney. It is diagnosed through a kidney biopsy and is characterized by damage to the kidney's blood vessels and tissues. Over time, this immune response can lead to a gradual decline in kidney function. The condition is resistant to conventional treatments, which typically include intravenous immunoglobulin therapy. Chronic antibody-mediated rejection can result in increased protein levels in the urine and may eventually require dialysis if kidney function continues to deteriorate.