BPAR rejection transplanted kidney
Conditions
Interventions
All patients will receive steroids according to the LUMC protocol and induction
treatment with basiliximab at day 0 and 4 (20 mg intravenously). Patients will
receive either 1 or 2 doses of 2x10^6 (
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female or male, aged between 18 and 75 years. 2. Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure. 3. Recipients of a first kidney graft from a living-unrelated or non-HLA identical living related donor. If a donor is > 50 years of age, recipient must be >25 years of age. 4. Panel Reactive Antibodies (PRA)
Exclusion criteria
Exclusion criteria: 1. Double organ transplant recipient. 2. Biopsy proven acute rejection (according to the Banff criteria) in the first 6 weeks after transplantation. 3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion. 4. Patients suffering from hepatic failure. 5. Patients suffering from an active autoimmune disease. 6. Patients who have had a previous BM transplant. 7. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 8. Use of any investigational drug after transplantation. 9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria. 10. Subjects who currently have an active opportunistic infection at the time of MCA-derived MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation. 11. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria. 12. Known recent substance abuse (drug or alcohol). 13. Patients who are recipients of ABO incompatible transplants. 14. Cold ischemia time >30 hrs. 15.Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable). 16. Repeated HLA mismatch present between the MCA-derived MSC and the mismatches between donor and kidney graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the incidence of BPAR/graft loss after MCA-derived MSC treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Renal function by calculated GFR , eGFR (CKD-EPI formula) and iohexol clearance - CMV and BK infection (viremia, disease and syndrome and subtype of BK). - Donor specific HLA sensitization by luminex before and after MSC infusions - Immune monitoring before and after MSC treatment - Incidence and severity of reported SAEs and AEs at 12 months | — |
Countries
Netherlands
Outcome results
None listed