Table 2.

Ongoing National Institutes of Health–registered clinical trials of MSCs in kidney diseases

NCT	Sponsor	Patient Population	Cell Source	Route, Dose	Timing	Primary Study End Point	Phase, Status
Kidney transplantation
NCT02012153a	Mario Negri Institute for Pharmacological Research, Italy	Living donor kidney transplant recipients	Autologous BM	Single iv injection, 1–2×106/kg	Day −1 pre-tx	Safety and biologic/mechanistic study	Phase 1 recruiting
NCT02057965  (Triton Study)	Leiden University Medical Center, The Netherlands	Deceased or living donor kidney transplant recipients	Autologous BM	Double iv injections, 1–2×106/kg/each	Post-tx weeks 6 and 7	To evaluate whether MSCs in combination with everolimus facilitate tacrolimus withdrawal, reduce fibrosis, and decrease the incidence of opportunistic infections	Phase 2 recruiting
NCT02387151  (Neptune   Study)	Leiden University Medical Center, The Netherlands	Living donor kidney transplant recipients	Allogeneic BM (not sharing HLA mismatches with the donor)	Double iv injections, 1–2×106/kg per each	Post-tx weeks 25 and 26	Safety (by the composite end point biopsy-proven acute rejection/graft loss at 12 mo)	Phase 1 recruiting
NCT02490020	Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China	DCD donor kidney transplant recipients	BM, whether autologous or allogeneic not specified	Single iv injection, 2×106/kg combined or not with intra-arterial injection of 5×106 MSCs	48 h before tx	Incidence of biopsy-proven acute rejection and delayed graft function	Phase 1 enrolling by invitation
NCT02492308	Fuzhou General Hospital, Fujian, China	Living donor kidney transplant recipients	Autologous adipose tissue	Four doses, cell dose and route not specified	Post-tx days 0, 7, 14, and 21	To evaluate whether MSC therapy allows reducing 30% the dose of CNI	Phase 1/2 recruiting
NCT02409940a	Postgraduate Institute of Medical Education and Research, Chandigarh, India	Living donor kidney transplant recipients	Either autologous or allogeneic (donor-derived) BM	Double iv injections, 1–2×106/kg per each	Days −1 pre-tx and day +30 post-tx	Expansion of Tregs	Phase 1 ongoing, not recruiting
NCT02561767	First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China	DCD donor kidney transplant recipients	Allogeneic BM	Four iv injections, 1×106/kg per each	Days 0, 7, 14, and 21 post-tx	Safety and efficacy (renal allograft function, rejection, patient/graft survival)	Phase 1/2 not yet open
NCT02563366	First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China	DCD donor kidney transplant recipients with poor early graft function	Allogeneic BM	Four consecutive weekly iv injections, 1×106/kg per each	At manifestation of early poor graft function	Graft function recovery (eGFR at 1 mo post-tx)	Phase 1/2 not yet open
NCT02563340	First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China	Kidney transplant recipients with chronic antibody-mediated rejection	Allogeneic BM	Four iv injections, 1×106/kg per each	Every 2 wk for four consecutive doses at diagnosis of AMR	Safety and efficacy (renal allograft function, DSA levels, pathologic features, patient/graft survival)	Phase 1/2 not yet open
NCT02565459	Mario Negri Institute for Pharmacological Research, Italy	Deceased donor kidney transplant recipients	Allogeneic BM	Single iv injection, 1–2×106/kg	Day 0	Safety and biologic/mechanistic study	Phase 1 recruiting
NCT01429038a	University Hospital of Liege, Liege, Belgium	Patients with renal or liver transplant	Allogeneic BM (no HLA matching with recipients and donors)	Single iv injection, 1.5–3×106/kg	Day 3±2 post-transplant	Safety and tolerability	Phase 1/2 unknown
NCT00659620	Fuzhou General Hospital, Fujian, China	Kidney transplant recipients with chronic allograft nephropathy	Not specified	Not specified	Day 0	To evaluate whether MSC therapy prevents rejection and maintenance of graft function	Phase 1/2 unknown
AKI
NCT01275612	Mario Negri Institute for Pharmacological Research, Italy	Patients with solid organ cancers who developed acute renal failure after chemotherapy with cisplatin	Allogeneic BM	Single iv injection, dose escalation: 1×106, 2×106, and 5×106 MSCs per kilogram	n.a.	Safety and feasibility to improve kidney function	Phase 1 recruiting
NCT03015623	Sentien Biotechnology Inc.	Subjects with AKI receiving continuous RRT	Allogeneic MSC device (SBI-101)	Extracorporeal therapy with device containing 250 or 750 million MSCs	n.a.	Safety and tolerability	Phase 1/2 not yet open
CKDs
NCT02195323	Royan Institute, Teheran, Iran	Patients with CKDs	Autologous BM	Single iv injection, 2×106/kg	n.a.	Safety	Phase 1 completed, no results available
NCT02585622  (NEPHSTROM  Study)	Mario Negri Institute for Pharmacological Research, Italy	Subjects with T2D and progressive DKD	Allogeneic BM (ORBCEL-M)	Single iv injection, dose escalating 80×106, 160×106, 240×106	n.a.	Safety, feasibility, and tolerability	Phase 1/2 not yet open
NCT02266394	Mayo Clinic in Rochester	Patients with advanced renovascular disease	Autologous adipose tissue	Single intra-arterial injection, dose not specified	n.a.	To evaluate whether MSCs before percutaneous transluminal renal angioplasty with stenting enhance changes in single kidney blood flow and restoration of kidney function	Phase 1 recruiting
NCT00659217	Organ Transplant Institute, Fujian, China	Patients with lupus nephritis	Autologous BM	Not specified	n.a.	Improvement of lupus disease	Phase 1/2 unknown
NCT02633163  (MsciSLE   Study)	Medical University of South Carolina	Patients with SLE	Allogeneic, UC	Single iv injection, 1×106 or 5×106/kg,	n.a.	Safety and efficacy in inducing clinical response	Phase 2 not yet open

NCT, ClinicalTrials.gov identifier; iv, intravenous; tx, transplantation; DCD, donation after cardiac death; AMR, antibody-mediated rejection; DSA, donor-specific antibody; n.a., not applicable; NEPHSTROM, Novel Stromal Cell Therapy for Diabetic Kidney Disease; MsciSLE, MSCs in SLE Trial.

^aPreliminary data are available (Table 1); for the NCT01429038 trial, data in patients with liver transplants have been published.⁶⁵