Chronic active antibody mediated rejection
Conditions
Brief summary
1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy
Detailed description
1. Kidney function assessment: change in eGFR from before MSC infusion to after. 2. Chronic kidney rejection/damage assessment: change in kidney biopsy/histology, imaging and urinary findings from before MSC infusion to after. 3. Adverse events assessment: number of grade 3 or higher AEs attributable to MSC infusion 4. Anti-donor immune response assessments: changes in DSAs, immune cells and inflammation markers from before MSC infusion to after. 5.Opportunistic infection assessment: changes in
Interventions
DRUGMSC
DRUGadipose tissue
Sponsors
Region Midtjylland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Kidney function assessment: change in eGFR from before MSC infusion to after. 2. Chronic kidney rejection/damage assessment: change in kidney biopsy/histology, imaging and urinary findings from before MSC infusion to after. 3. Adverse events assessment: number of grade 3 or higher AEs attributable to MSC infusion 4. Anti-donor immune response assessments: changes in DSAs, immune cells and inflammation markers from before MSC infusion to after. 5.Opportunistic infection assessment: changes in | — |
Outcome results
None listed