Safety and Efficacy Endpoints for Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients

Table 2

Objectives of currently registered and performed trials with allogeneic MSCs in renal transplantation.

Trial/study phase/outcome	Primary endpoint	Secondary endpoints
Allogeneic MSC therapy in renal transplant recipients; pPhase I; Recruiting. ClinicalTrials.gov identifier: NCT02387151	Safety; (BPAR and graft loss)	(i) Histology (fibrosis by Sirius red); (ii) Renal function (iohexol, MDRD); (iii) (Serious) adverse events; (iv) (Opportunistic) infections; (v) Development of de novo DSAs; (vi) Immune monitoring (One study)
Intraosseous injection of donor-derived MSCs into the bone marrow in living-donor kidney transplantation; a pilot study; phase I; Injection into iliac bone was safe, no adverse events. Three patients suffered from acute rejection. Mixed chimerism was not detected [16].	Adverse events	(i) (Opportunistic) infections; (ii) Histology; (iii) BPAR (Banff); (iv) Chimerism analysis (STR-PCR); (v) Foxp3 quantitation (qPCR); (vi) Functional assays (MLR, cytokines)
Donor- derived MSCs with low-dose Tacrolimus prevents acute rejection after renal transplantation; phase I; Injection of MSCs into renal artery was safe and feasible. Chimerism was not detected. More peripheral B cells in MSC group [15].	Safety of MSC infusion	(i) BPAR; (ii) Graft function (Cr); (iii) Patient and graft survival; (iv) Immune monitoring lymphocytes (flow cytometry); (v) Functional assays (MLR); (vi) Chimerism (STR-PCR)
Infusion of third-party MSCs after renal or liver transplantation; phases I-II; Recruiting. ClinicalTrials.gov identifier: NCT01429038	(i) Safety of MSC infusion; (ii) Incidence, timing, and severity of    infections and malignancies	(i) Patient and graft survival; (ii) Graft function (creatinine, HD after transplant); (iii) BPAR; (iv) Immune function (flow cytometry, TREC quantification, Vβ repertoire diversity, and pathogen-specific T cells); (v) Anti-MSC and anti-organ donor HLA antibodies

MSCs: mesenchymal stromal cells; BPAR: biopsy proven acute rejections; Cr: creatinine; MDRD: modification of diet in renal disease; STR-PCR: short tandem repeat polymerase chain reaction; HD: hemodialysis; DSAs: donor specific antibodies; HLA: human leukocyte antigen; qPCR: quantitative PCR.