Health Condition 1: null- End stage renal disease requiring renal transplantation
Conditions
Interventions
Intervention1: Stem cell therapy: Methyl prednisolone, Rituximab, Bortezomib, rabbit anti thymocyte globulin
Control Intervention1: Renal transplantation with stem cell therapy Vs. Renal Transplanta
Sponsors
Self
Eligibility
Inclusion criteria
Inclusion criteria: Established end stage renal disease/ Chronic renal failure; Donor with matching blood group
Exclusion criteria
Exclusion criteria: HIV positive/ AIDS; HBsAg/ HCV positive; Any malignancy; DM/ Tuberculosis; Advanced coronary artery disease; Reflux disease; Active anti-phospholipid syndrome/ Lupus Nephritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Viability, sterility, quantity and characterization of stem cells and donor leucocytes 2. Safety of stem cell therapy and donor specific leucocyte transfusion(DST) - Patient survival 3. Infections or any other adverse side effects due to Tolerance Induction Protocol including conditioning or SCT/ DST in any patient of both groups.Timepoint: 1. Immediately after generation of the stem cells and DST and for next 48 hours. 2. Daily monitoring till 30 days post-transplant, alternate days for next 15 days, twice a week for next 1 month (till 3 months post-transplant), weekly till 6 months post-transplant, fortnightly till 7th month and monthly thereafter for first year, every 2 months for second year, and every 3 months thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Graft function and graft versus host disease (GVHD) in both groups. 2. Graft survival 3. Immunosuppression requirement 4. Rejection- biopsy and clinical 5. Measurement of donor specific antibodies 6. Mixed lymphocyte reactionTimepoint: 1. Immediately after stem cells/ DST infusion. 2. Daily monitoring till 30 days post-transplant, alternate days for next 15 days, twice a week for next 1 month (till 3 months post-transplant), weekly till 6 months post-transplant, fortnightly till 7th month and monthly thereafter for first year, every 2 months for second year, and every 3 months thereafter. | — |
Countries
India
Contacts
Public ContactAruna V Vanikar
Institute of Kidney Diseases and Research Centre, Institute of Transplantation Sciences
Outcome results
None listed