Renal Transplant Rejection Clinical Trial
Official title:
A Randomized Trial to Elucidate Effect of Mesenchymal Stem Cells on Immune Modulation in Living Related Kidney Transplant Patients
Despite being a miracle of modern medicine, solid organ transplant recipients are always at
risk of rejection, and remain dependent on lifelong immunosuppression. Currently used
immunosuppressive drugs suppress the potential of immune system and interfere with the
metabolism of medications. Cellular therapies currently being investigated for this purpose
require the use of ablative radiotherapy. The investigators are using a less toxic strategy
by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx)
recipients and studying immunomodulation mediated by these cells in the KTx patients.
Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and
Dendritic cells which leads to improve graft survival of renal transplant patients.
Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated
response.
The investigators aim to collect peripheral blood from 30 patients (10 patients for
autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time
intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but
without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear
cells and performing various immune assays on these cells in a donor specific response.
This is an open label type of study having 3 groups of patients: 1st group comprising of patients that would undergo allogeneic (donor-derived) mesenchymal stem cell infusion, 2nd group that would undergo autologous (patient-derived) mesenchymal stem cells and the third group (control group) without any stem cell infusion. All the three groups would have standard dose of Immunosuppressive drugs. Initially the investigators want to recruit 10 patients in each group and would increase the group size if the investigators get promising results on the follow up. The investigators plan to follow up the patients upto 1-2 years for immune based assays and then continue the follow up for atleast 5 years. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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