Allogeneic adipose-derived mesenchymal stem cells in vitro expanded for Chronic active antibody-mediated rejection

Inclusion criteria

• {"criterion_text":"- A.\tBiopsy proven diagnosis of ca-ABMR according to Banff 2017 with following 3 criteria: 1) Morphologic evidence of chronic tissue injury 2) Current/recent antibody interaction with vascular endothelium 3) Serologic evidence of circulating DSA to HLA."}
• {"criterion_text":"- B.\tAge between 18 and 75 years of age."}
• {"criterion_text":"- C. Renal transplant recipient first or repeat at least 6 months prior to screening."}
• {"criterion_text":"- D. eGFR > 20 ml/min."}
• {"criterion_text":"- E. Written, informed consent prior to study inclusion."}
• {"criterion_text":"- F.\t If female and child-bearing potential, subject must be non-pregnant, non-breastfeeding and use adequate contraception."}

Exclusion criteria

• {"criterion_text":"- a.\tMultiorgan transplant recipient except for simultaneous kidney-pancreas or previous multiple renal transplants or cell transplants (islet or bone marrow)."}
• {"criterion_text":"- b.\tBiopsy proven acute rejection (according to the Banff criteria) in the 4 weeks prior to inclusion."}
• {"criterion_text":"- c.\tExcept for steroids, other treatments for ABMR or TCMR are not allowed within 3 months prior to the start of screening."}
• {"criterion_text":"- d.\tOn dialysis or expected to commence on dialysis within 3 months of inclusion."}
• {"criterion_text":"- e.\tEvidence of active bacterial or viral infection, (except for an uncomplicated urinary tract infection) (e.g., CMV, Pneumocystis carinii (PCP), HIV, hepatitis B/C, aspergillosis, histoplasmosis, or mycobacteria)."}
• {"criterion_text":"- f.\tA psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study."}
• {"criterion_text":"- g.\tUse of any current investigational drug."}
• {"criterion_text":"- h.\tMalignancy (including lymphoproliferative disease) within the past 2 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence)."}
• {"criterion_text":"- i.\tUnwilling or unable to adhere to study requirements and procedures"}

Primary endpoints

• {"endpoint_text":"- 1.\tFeasibility: number of participants treated with MSC infusion","definition_or_measurement_approach":"Count of participants who receive the MSC infusion (number treated)."}
• {"endpoint_text":"- 2.\tSafety: number of participants without infusional toxicity","definition_or_measurement_approach":"Count of participants without infusion-related toxicity events."}
• {"endpoint_text":"- 3.\tClinical: number of participants without graftloss/death/nephrectomy","definition_or_measurement_approach":"Count of participants who do not experience graft loss, death, or nephrectomy."}

Secondary endpoints

• {"endpoint_text":"- 1.\tKidney function assessment: change in eGFR from before MSC infusion to after.","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) measured before MSC infusion and at specified post-infusion timepoints."}
• {"endpoint_text":"- 2.\tChronic kidney rejection/damage assessment: change in kidney biopsy/histology, imaging and urinary findings from before MSC infusion to after.","definition_or_measurement_approach":"Comparison of kidney biopsy/histology scores, imaging and urinary biomarkers before and after MSC infusion."}
• {"endpoint_text":"- 3.\tAdverse events assessment: number of grade 3 or higher AEs attributable to MSC infusion","definition_or_measurement_approach":"Count of grade ≥3 adverse events judged attributable to MSC infusion using standard AE grading."}
• {"endpoint_text":"- 4.\tAnti-donor immune response assessments: changes in DSAs, immune cells and inflammation markers from before MSC infusion to after.","definition_or_measurement_approach":"Measurement of donor-specific antibodies (DSAs), immune cell populations and inflammatory markers pre- and post-infusion and comparison of changes."}
• {"endpoint_text":"- 5.Opportunistic infection assessment: changes in","definition_or_measurement_approach":"Not fully specified in the source (text truncated); intended to assess changes in opportunistic infection occurrence or markers before and after infusion."}

Denmark

Earliest CTIS Part Ii Submission Date

26-02-2026

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

11

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Midtjylland","duties_or_roles":"sponsorDuties codes: [14,4]; contact email: auh.center.gen-.og.celleterapi@rm.dk","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: [1,9]; contact email: gcp@clin.au.dk","organisation_type":"Educational Institution"}