Organ Transplantation Clinical Trial
Official title:
Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Allograft Rejection After Renal Transplantation
The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in IF?TA in the renal biopsy 4 weeks or 6 months after renal transplantation.
Kidney transplantation has improved survival and quality of life for patients with end-stage
organ failure. Despite dramatic improvements in short-term survival, long-term survival of
renal allografts has changed little during the past decade. Recently, it has been
demonstrated that chronic lesions originate already very early after transplantation and
that subclinical rejection (SCR) in protocol biopsies is a risk factor for late graft loss.
However the efficacy of high-dose corticosteroids and other therapies for the treatment of
SCR have been shown to be inadequate. Thus, despite the availability of a range of available
medications there remains a need for therapeutic alternatives because patients may not
respond to existing therapeutic choices, they do not show an improvement of the fibrosis
reaction or an effect on long term survival, or they may develop immunosuppression induced
serious (sometimes fatal) side effects and toxicities.
In recent years it has become evident that bone marrow (BM) derived mesenchymal stem cells
have potent immunomodulatory effects. MSCs are pluripotent cells that can differentiate into
several mesenchymal tissues, including fibroblasts, osteoblasts, adipocytes and chondrocyte
progenitors. MSCs have potent immunosuppressive effects on T and B cells in vitro and in
animal models of chronic inflammation. Encouraging results have been obtained in patients
with steroid resistant acute and severe Graft versus Host Disease (GvHD). The investigators
hypothesize that infusion of MSCs may similarly provide a novel treatment option in the
treatment of patients with allograft rejection with less side effects than existing
immunosuppressive therapies.This study will evaluate the safety and feasibility of MSC
therapy in renal recipients.
In total 15 de novo renal recipients of 2 HLA-DR mismatched living donors, men and women,
18-65 years of age, will be recruited from the renal transplant clinics of the LUMC. Only
patients with SCR abd or an increase in IF/TA in the protocol biopsy 4 weeks or 6 months
after transplantation will receive MSC infusions. MSCs from patients without SCR in their
biopsy will be only used for feasibility and function studies (as described earlier).
Subjects will receive two doses of 1 x 10.6 MSCs per kilogram body weight, intravenously, 7
days apart. The investigators will investigate safety of MSC therapy by assessing the rate
of (serious) adverse events in the study population using the World Health Organization
(WHO) criteria. Feasibility will be obtained by determining the number of expanded MSCs in
relation to the amount of BM collected, number of passages required and time to reach study
target doses.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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