SCARR : « Allogenic Umbilical Cord Mesenchymal Stromal Cells for the treatment of chronic renal (cABMR) graft rejection »

Conditions

Adult Patients kidney transplant recipients who have developed chronic humoral rejection, diagnosed through a kidney biopsy (Banff 2017 Classification), resistant to conventional treatment (3 injections at one-month intervals of 2g/kg of IVIG)

Brief summary

Change in renal function (estimated glomerular filtration rate CDK-EPI) (eGFR) between D0 and M24

Detailed description

Safety of UC-MSC injection (after injection for 4 hours): Measurement of pulsed oxygen saturation, dyspnea, blood pressure, eGFR, CRP, cellular infiltration (BANFF 2017 criteria for the evaluation of acute rejection), Variation in renal function (eGFR) on D0, M1, and respectively M2, M6, and M12, M18 and M24, Cumulative incidence of patients requiring dialysis at 12 and 24 months., Evolution of 24-hour proteinuria and the proteinuria/creatininuria ratio between D0 and M1, M2, M6 and M12, M18 and M24, Luminex assay for donor-specific anti-HLA antibodies (single antigen) on D0, M2, M6, M12, M24, Quantification of Interstitial Fibrosis and Tubular Atrophy, glomerulitis, and capillaritis on histological section. Quantification of fibrosis by Syrius Red and immunohistochemistry at 6 months, T and B lymphocyte phenotyping (% of T and B regs) on D0, M2, M6

Related papers

No related papers found yet.

Interventions

DRUGSolution de chlorure de sodium à 0

DRUG9%

DRUGAllogeneic umbilical cord derived MSC (thawed and washed)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in renal function (estimated glomerular filtration rate CDK-EPI) (eGFR) between D0 and M24	—

Secondary

Measure	Time frame
Safety of UC-MSC injection (after injection for 4 hours): Measurement of pulsed oxygen saturation, dyspnea, blood pressure, eGFR, CRP, cellular infiltration (BANFF 2017 criteria for the evaluation of acute rejection), Variation in renal function (eGFR) on D0, M1, and respectively M2, M6, and M12, M18 and M24, Cumulative incidence of patients requiring dialysis at 12 and 24 months., Evolution of 24-hour proteinuria and the proteinuria/creatininuria ratio between D0 and M1, M2, M6 and M12, M18 and M24, Luminex assay for donor-specific anti-HLA antibodies (single antigen) on D0, M2, M6, M12, M24, Quantification of Interstitial Fibrosis and Tubular Atrophy, glomerulitis, and capillaritis on histological section. Quantification of fibrosis by Syrius Red and immunohistochemistry at 6 months, T and B lymphocyte phenotyping (% of T and B regs) on D0, M2, M6	—

Measure

Time frame

Safety of UC-MSC injection (after injection for 4 hours): Measurement of pulsed oxygen saturation, dyspnea, blood pressure, eGFR, CRP, cellular infiltration (BANFF 2017 criteria for the evaluation of acute rejection), Variation in renal function (eGFR) on D0, M1, and respectively M2, M6, and M12, M18 and M24, Cumulative incidence of patients requiring dialysis at 12 and 24 months., Evolution of 24-hour proteinuria and the proteinuria/creatininuria ratio between D0 and M1, M2, M6 and M12, M18 and M24, Luminex assay for donor-specific anti-HLA antibodies (single antigen) on D0, M2, M6, M12, M24, Quantification of Interstitial Fibrosis and Tubular Atrophy, glomerulitis, and capillaritis on histological section. Quantification of fibrosis by Syrius Red and immunohistochemistry at 6 months, T and B lymphocyte phenotyping (% of T and B regs) on D0, M2, M6

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Countries

France

Outcome results

None listed