Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplantation

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for a condition called chronic antibody-mediated rejection (cABMR) in kidney transplant patients. cABMR can happen when the body’s immune system attacks the transplanted kidney, which can lead to loss of kidney function. The researchers want to see if using special cells from umbilical cords, known as mesenchymal stromal cells (MSCs), can help improve kidney function and reduce the need for other medications that suppress the immune system. This trial aims to find out if these cells can help patients whose kidneys are showing signs of rejection after their transplant.

To be eligible for this trial, participants must be adults aged 18 or older who received a kidney transplant between 1 and 10 years ago and have been diagnosed with cABMR. They should also have specific blood test results that show their body is not responding to standard treatments. Participants will receive injections of the umbilical cord MSCs and will be monitored closely to see how their kidney function changes over time. This trial is not yet recruiting participants, but it represents an exciting step towards finding new treatments for those struggling with kidney transplant rejection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or Female aged ≥18 years
• • Renal transplant recipient for ≥1 year and \<10 years
• • Chronic humoral rejection diagnosed by renal biopsy (Banff 2017) within the last 6 months (cpt+g score ≥ 2) with donor-specific anti-HLA antibodies (MFI\<10000) and unresponsive to 3 monthly IV-IG treatments (2 g/kg) (persistence of histological lesions of Chronic Humoral Rejection; no improvement in eGFR \>20%; proteinuria/creatinine ratio not regressed by more than 50% and DSA not regressed by 50%)
• • eGFR (CDK-epi) \> 30ml/min
• • Proteinuria \>1 g/24h or proteinuria/creatinine ratio \>150 mg/mmol
• • Patient able to attend follow-up consultations
• • Patient capable of understanding and following the protocol
• • Signed informed consent from the patient
• • Affiliation to a social security system
• Exclusion Criteria:
• • Multiple transplant
• • HIV-positive patient or patient with an acute or chronic uncontrolled viral infection such as hepatitis B or C
• • Patient with an active bacterial infection
• • Patient with decompensated heart failure or known ejection fraction \<40%
• • Patient with known liver cirrhosis or liver failure (Factor 5 \<50%) or hepatic cytolysis (ALT \>5N)
• • Patient treated for a solid tumor or hematopoietic malignancy in the past 5 years, excluding skin tumors (except melanoma) (less than 3 skin tumors) BK virus nephropathy diagnosed by renal biopsy or presumed (2 BK virus PCR \> 10\^4 for 3 weeks) at the time of inclusion
• • Pregnant woman or woman of childbearing age not using effective contraception during her participation in the study
• • Patient with a known or suspected contraindication to the administration of any product used in the study, including the active substance or any excipients
• • Patient deprived of liberty by judicial or administrative decision
• • Adult patient under legal protection (guardianship, curatorship, or legal safeguard)
• • Patient receiving psychiatric care and not stabilized
• • Participation in another interventional clinical trial involving humans or in the exclusion period following a previous clinical trial involving humans (corresponding to the half-life of the experimental drug)
• • Patient who received treatment with Rituximab or Velcade within the 12 months prior to inclusion and has chronic humoral rejection resistant within the past year
• • Patient under state medical assistance (AME)