Table 1 Registered clinical trials testing the efficacy of MSCs in kidney
From: Stem cells: a potential treatment option for kidney diseases
Recipients | Source | Administration route | Primary endpoint | Secondary endpoint | Dose | Follow-up period | Trial registration | Ref. |
|---|---|---|---|---|---|---|---|---|
AKI | ||||||||
 Patients with high risk of developing AKI following heart surgery | Allogeneic BM-MSCs | Intra-aortic | Safety, as documented by comparing the incidence of adverse events, serious adverse events, and complications | Efficacy of MSC administration for prevention and treatment of postoperative AKI | NA | 6 months | NCT00733876 | |
 Patients undergoing cardiac surgery with evidence of early AKI | Allogeneic MSCs | Intra-aortic | The time to recover kidney function was defined as return of postintervention creatinine levels to baseline | Included all-cause mortality or provision of dialysis at 30 and 90 days post-study drug administration | 2 × 106cells/kg | 90 days | NCT01602328 | [161] |
CKD | ||||||||
 CKD patients (eGFR 15–60 mg/ml) | Supernatants of hCB-MSCs | Intravenous and intra-arterial | The safety of the therapy through for a period of 1 year | The efficacy of treatment assessed by duplication of eGFR or 50% reduction of serum creatinine from the baseline level of each patient | 100 μg/kg | 12 months | NA | [162] |
 Type 2 DN patients | Allogeneic BM-MPCs | Intravenous | The safety and tolerability, including the number and percentage of subjects with adverse events and serious adverse events, clinically significant values and shifts from baseline in vital signs, and clinical laboratory tests | Efficacy change from baseline in eGFR and directly measured GFR by 99Tc-DTPA plasma clearance at 12 weeks post-infusion | 150 × 106 or 300 × 106 cells/kg | 60 weeks | NCT01843387 | [163] |
 CKD patients (eGFR 20–40 ml/min/1.73 m2) | Autologous AT-MSCs | Intravenous | The eGFR and quantitative 24-h urinary protein excretion rate for a period of 12 months | Clinical or biochemical changes suggestive of treatment-associated adverse events or warnings | 1 × 106 cells/kg | 12 months | NA | [164] |
 CKD patients (eGFR 25–60 ml/min/1.73 m2) | Autologous BM-MSCs | Intravenous | The safety was measured by number and severity of adverse events | Decrease in the rate of decrease in eGFR | 1–2 × 106 cells/kg | 18 months | NCT02195323 | [165] |
 RVD patients | Autologous AD-MSCs | Intra-arterial | 1. Change in kidney function 2. Safety of mesenchymal stem cell infusion | Decrease in kidney inflammation | 1.0 × 105 or 2.5 × 105cells/kg | 3 months | NCT02266394 | [166] |
 ADPKD patients | Autologous BM-MSCs | Intravenous | The numbers, type, and severity of AEs | Changes in eGFR from baseline to 12 months after cell infusion | 2 × 106 cells/kg | 12 months | NCT02166489 | [167] |
 Patients with active and refractory LN | Allogeneic BM-MSCs (n = 23) or hUC-MSCs (n = 58) | Intravenous | Remission of nephritis (CR and PR) as well as renal flares within 12 months | SLEDAI score for disease activity, BILAG score of renal system, and changes in renal function, serum albumin, and anti-dsDNA antibody levels pre- and post-MSCT | 1 × 106 cells/kg | 12 months | NA | [173]. |
 Patients with class III or IV LN | hUC-MSCs | Intravenous | Remission of nephritis was defined as stabilization or improvement in renal function, urinary red blood cells of less than 10 per hpf, and reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day or at least a 50% reduction in proteinuria or to less than 1 g/day if baseline proteinuria was in the subnephrotic range | Improvement in SLEDAI and BILAG scores, complement concentration, anti-dsDNA (double-stranded DNA) antibody and ANA titers, death and commencement of permanent dialysis or renal transplantation | 2 × 108 cells/kg | 12 months | NCT01539902 | [174] |
Renal transplantation | ||||||||
 Kidney transplant recipients | Autologous BM-MSCs | Intravenous | Assessing the percentage of inhibition of memory T cell response and/or naive T cell response, the induction of donor-reactive T cell anergy, and the appearance in the peripheral blood of regulatory T cells | Safety parameters related to MSC infusion, graft function, graft rejection | 2 × 106/kg | 1 year | NCT00752479 | |
 Kidney transplant recipients | Allogeneic BM-MSCs | Intravenous | Adverse effects of MSC infusion as well as infectious and malignant complications at 1 year | Effect of MSCs on graft outcomes and immunity as well as the occurrence of anti-MSC-DSAs | 1.5 × 106–3 × 106 cells/kg | 1 year | NCT01429038 | [179] |
 Kidney transplant recipients | Autologous BM-MSCs | Intravenous | Changes of regulatory T cells and serum creatinine | Changes T cell proliferation, regulatory T cells, memory T cells, B cells, and cytokine profile | 0.2–0.8 × 106/kg | 6 months | NCT02409940 | [180] |
 Kidney transplant recipients | Autologous BM-MSCs | Intravenous | 1. Rate of (serious) adverse events in the study population 2. Feasibility: determination of the number of expanded MSCs in relation to the amount of BM collected, number of passages required, and time to reach study target doses | 1. Presence of late acute rejection (at 6-month biopsy when compared with 4-week biopsy) 2. Sirius red staining for renal cortical matrix accumulation. 3. Immunologic response before and after MSC infusion | 1 × 106 cells/kg | 24 weeks | NCT00734396 | [181] |
 Kidney transplant recipients | Autologous BM-MSCs | Intravenous | 1-year incidence of acute rejection and renal function eGFR | Patient and graft survival and incidence of adverse events | 1–2 × 106 cells/kg | 30 months | NCT00658073 | [183] |