Status:
NOT_YET_RECRUITING
Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplantation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Chronic Antibody-mediated Rejection (cABMR)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Kidney transplantation is the best treatment for end-stage chronic kidney disease (CKD), improving survival and quality of life, while reducing treatment costs. However, immunosuppressive therapies re...
Detailed Description
Currently, for patients with active chronic antibody-mediated rejection (cABMR) who do not respond to IV immunoglobulin (IV-Ig) infusions, there is no treatment that controls the rejection. Treatments...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2029
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06886646
Start Date
September 15 2025
End Date
October 15 2029
Last Update
June 26 2025
Active Locations (1)
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1
Hôpital Henri Mondor
Créteil, Créteil, France, 94010