Perico et al. (2011) |
rATG (0.5 mg/kg/day, days 0-6; Basiliximab (20 mg, days 0 and 4); steroids (days 0-7) |
CSA, MMF |
2 / LRD |
Autologous |
Bone marrow / Intravenous |
1.7-2.0 / single dose |
Day 7 |
-
–
↑ Tregs/Memory CD8 lymphocytes ratio
-
–
Pulse with MP in the third week (↑ creat)
-
–
Absence of DSA class I and class II
|
Tan et al. (2012) |
Basiliximab (20 mg, days 0 and 4) only in the control group |
ICN, MMF, steroids: |
159 / LRD:
|
Autologous |
Bone marrow / Intravenous |
1.0 - 2.0 |
Days 0 and 14 |
-
–
↓ acute rejection in 6 months (~ 7% versus 21.6%)
-
–
↓ viral infection (~ 9% versus 29%)
-
–
no difference in eGFR in 12 months
|
Perico et al. (2013) |
rATG (0.5 mg/kg/day, days 0-6; steroids (days 0-7) |
CSA, MMF |
2 / LRD |
Autologous |
Bone marrow / Intravenous |
2.0 /single dose |
Day 1 |
|
Reinders et al. (2013) |
Basiliximab (20 mg, days 0 and 4) |
CNI, MMF, steroids |
6 / LRD |
Autologous |
Bone marrow / Intravenous |
1-2 /2 doses with a 1-week interval |
6-10 months: SCR with 4 weeks or SCR and/or IF/TA with 6-10 months in renal biopsy |
|
Peng et al. (2013) |
Cyclophosphamide 200 mg/day for 3 days and MP for 3 days (750 mg/250 mg and 250 mg/day) |
TAC, MMF, steroids |
12 / LRD (6 controls and 6 with 50% TAC and MSCs) |
Allogeneic |
Bone marrow / Intravenous |
5.0 via the renal artery and 2.0 intravenously / 2 doses |
Renal artery on the day of the transplant and intravenous after 1 month |
-
–
no difference in acute rejection and in eGFR after 12 months
-
–
MSCs group: higher levels of B-lymphocytes after 3 months
-
–
Absence of chimerism after 3 months
|
Reinders et al. (2015) Stage Ib; Neptune Study |
Basiliximab (20 mg, days 0 and 4) |
CNI, MMF, steroids |
10 / LRD |
Allogeneic |
Bone marrow / Intravenous |
2.5 2 doses(1-week interval) |
25 and 26 weeks |
-
–
Ongoing study
-
–
Primary outcomes: acute rejection confirmed by biopsy and renal graft loss
-
–
Secondary outcomes: fibrosis, DSA, immunological tests, eGFR, opportunistic infections
|
Mudrabettu et al. (2015) |
rATG (1 mg/kg) for 3 consecutive days |
TAC, MMF, steroids |
4/ LRD and LUD |
Autologous |
Bone marrow / Intravenous |
0.21-2.4/ 2 doses |
1 day before transplantation and 1 month after transplantation |
-
–
No early or late dysfunction of renal graft
-
–
Absence of viral infection
-
–
↑ Tregs
-
–
↓ proliferation of CD4 lymphocytes
|
Pan et al. (2016) |
Cyclophosphamide 200 mg/day for 3 days and MP for 3 days (750 mg/250 mg and 250 mg/day) |
TAC, MMF, steroids |
32 (16 controls and 16 treated with 50% TAC and MSCs) / LRD |
Allogeneic |
Bone marrow/ Renal artery and intravenous |
5.0 via renal artery and 2.0 intravenously / 2 doses |
Renal artery on the day of the transplant and intravenous after 1 month |
-
–
No difference in acute rejection, renal graft survival, serum creatinine, and eGFR
-
–
Absence of changes in responses to donor alloantigens in vitro
-
–
Immunophenotyping comparable of subpopulations of T lymphocytes
|
Sun et al. (2018) |
rATG (50 mg/day, for 3 consecutive days) |
CNI, MMF, steroids |
42 (21 controls and 21 treated with and MSCs) / DD |
Allogeneic |
Umbilical cord/ Intravenous + Renal artery |
2.0 Intravenously and 5.0 via renal artery / single doses on each route |
Intravenous: 30 minutes before the renal transplantation/ Renal artery at the time of transplantation |
-
–
No difference in delayed renal graft function, acute rejection, eGFR, patient and renal graft survival after 12 months
|
Vanikar et al. (2018) |
Protocol for induction of tolerance: non-myeloablative therapy with Bortezomib, MP, rATG, and Rituximab |
No conventional immunosuppression |
10 / LRD |
Allogeneic |
Hematopoietic cells of the bone marrow and adipose tissue /Intraportal |
0.22 ±0.16 of CD34+ cells from bone marrow mixed with 0.19 ±0.09 of MSCs of adipose tissue |
14 days before the transplant |
-
–
Acute cellular rejection: 3 patients (155 days, 33.4 months and 1.4 year)
-
–
Patient survival: 100% (2 years), 90% (3 years), and 80% (6 years): n= 1 pneumonia; n =1 sudden death and chronic graft dysfunction
-
–
Renal graft survival censored to death in 6 years: 90% (n=1 loss due to IF/TA)
-
–
2 patients with DSA, but without graft dysfunction
-
–
5 with conventional immunosuppression and 2 with mycophenolate
-
–
Serum creatine: 1.44± 0.41 mg/dl after 6 years
|
Erpicum et al. (2019) |
Basiliximab (20 mg, days 0 and 4) |
TAC, MMF and steroids (39% discontinued) |
20 (10 controls and 10 treated with MSCs) /DF |
Allogeneic |
Bone marrow / Intravenous |
mean 2.4 (2.0-2.6) / single dose |
3 ± 2 days after the transplant (2-5 days variation) |
-
–
1 patient with acute myocardial infarction 3 hours after infusion of MSCs
-
–
↑ Tregs in 30 days, but no difference after 1 year
-
–
No difference in proliferation of B lymphocytes
-
–
No difference in acute rejection and opportunistic infections - No difference in eGFR after 1 year
-
–
4 patients developed antibodies anti-MSCs (only 1 with MFI > 1,500)
|