fibrosis
Conditions
Interventions
Patients will receive two doses of allogeneic BM derived MSCs IV, 7 days apart,
25 and 26 weeks after transplantation^ (^time point of protocol biopsy and
further reduction of immune suppression). T
the recipient should have no antibodies
directed to the MSCs. Doses of MSCs will be 1x-2 million MSCs per/kg body
weight.
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. 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 4 weeks before MSC infusion. 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. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 7. Use of any investigational drug after transplantation. 8. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria. 9. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation. 10. 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. 11. Known recent substance abuse (drug or alcohol). 12. Patients who are recipients of ABO incompatible transplants. 13. Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (lipid lowering treatment with controlled hyperlipidemia is acceptable).*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is safety by assessing the composite end point of BPAR/graft loss after MSC treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of fibrosis by quantitative Sirius Red scoring at 52 weeks compared to 24 weeks post-transplant; de novo HLA antibody development by luminex (including C1q binding) before and after MSC infusions; renal function measured by cGFR (MDRD formula); CMV and BK infection (viremia, disease and syndrome and subtype of BK) and other opportunistic infections; immune monitoring after MSC treatment | — |
Countries
Netherlands
Outcome results
None listed