aandoeningen na niertransplantatie allograft rejection rejection after (renal) transplantation
Conditions
Interventions
MSC infusion: two doses of 1-2 miljon MSCs per kilogram body weight,
intravenously, 7 days apart.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female or male, aged between 18 and 65 years. 2. Subject is willing to participate in the study and has signed the informed consent. 3. Recipents of a first kidney graft from a living HLA-DR mismatched donor (2 HLA-DR mismatches). 4. Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation. 5. Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol. 6. Panel Reactive Antibodies (PRA)
Exclusion criteria
Exclusion criteria: 1. Double organ transplant recipient. 2. Acute clinical rejection after transplantation. 3. Patients with evidence of active infection or abcesses 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 (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) 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. Contraindications to undergo a BM biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Safety: rate of (serious) adverse events in the study population using the World Health Organization (WHO) criteria. 2 Feasibility: determination of the number of expanded MSCs in relation to the amount of BM collected, number of passages required and time to reach study target doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Presence of late acute rejection in the 6 month biopsy compared with the 4 week biopsy. 2 Sirius red staining for renal cortical matrix accumulation in the 6 month biopsy compared with the 4 week biopsy. 3 Immunologic response (immunologic properties of peripheral blood T cells before and after MSC infusion) after 6 months. | — |
Countries
Netherlands
Outcome results
None listed