Health Condition 1: null- End stage renal disease requiring renal transplantation
Conditions
Interventions
Intervention1: Tolerance induction protocol using stem cell therapy: PBSC, DST, HSCs, Ad-MSCs
Control Intervention1: Not applicable.: Not applicable.
Sponsors
Self
Eligibility
Inclusion criteria
Inclusion criteria: Established end stage renal disease/ Chronic renal failure; Donors with matching blood group
Exclusion criteria
Exclusion criteria: HIV positive/ AIDS; HBsAg/ HCV positive; Any malignancy; Advanced coronary artery disease;Active anti-phospholipid syndrome/ Lupus Nephritis; unrelated allograft donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Viability, sterility, quantity and characterization of donor leucocytes, peripheral blood stem cells, HSCs. 2. Safety of protocols 3. Patient survival 4. Infections /adverse side effectsTimepoint: 1. Immediately after their generation. 2. Every hour for 24 hours, 4 hourly for next 48 hours after stem cell therapy 6 monthly, Hourly for 24 hours, 4 hourly for next 48 hours, Daily monitoring till 30 days, twice a week for next 90 days, weekly till 6 months, 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 all groups. 2. Graft survival 3. Immunosuppression requirement 4. Rejection- biopsy and clinical Timepoint: 1. Daily till 30 days, twice a week for next 90 days, weekly till 6 months, fortnightly till 7th month and monthly thereafter for first year, every 2 months for second year, and every 3 months thereafter. 2. 6 monthly 3. in event of rise in serum creatinine, graft tenderness | — |
Countries
India
Contacts
Public ContactAruna V Vanikar
Institute of Kidney Diseases and Research Centre, Institute of Transplantation Sciences,
Outcome results
None listed