Fig. 9

Changes in peripheral blood Treg numbers after Mreg_UKR administration. a An example of Mreg_UKR manufactured under clean-room conditions. For the pharmaceutical release of Mreg_UKR products, the identity of Mreg cells is specified according to CD14, CD16, CD80, CD86, CD85h and CD258 expression. It is specified that impurity of Mreg_UKR products with CD3⁺ T cells must be ≤1%. It is further specified that Mreg cells must upregulate IDO expression as a marker of potency. DHRS9 expression is not specified as a product-release criterion; however, Mreg cells contained in Mreg_UKR products uniformly express DHRS9. b One week prior to living-donor kidney transplantation, patients in the ONEmreg12 trial are treated with a single dose of 2.5–7.5 × 10⁶ viable Mregs per kg by central i.v. infusion under cover of mycophenolate mofetil (MMF) 250 mg BD. One day prior to kidney transplantation, patients receive MMF 1 g BD and tacrolimus (Tac) treatment commences at a target serum trough level of 3–12 ng ml^-1. Patients receive an intraoperative steroid bolus, but no basiliximab (anti-IL-2Rα) induction therapy. c CD25⁺ CD127^int Treg frequencies in peripheral blood of Mreg-treated patients assessed prior to Mreg infusion and 1 day before transplantation. Results from five patients are shown, including two participants of the TAIC-II Study whose cases were previously reported elsewhere. d In the case of patient C3157, serial blood samples were collected for measurement of CD4⁺ CD25⁺ FoxP3⁺ Tregs prior to Mreg infusion and at close intervals over the 6 days before transplantation (values represent mean ± sd of replicate stainings). e The observed increase in peripheral blood Treg frequency in patient C3157 could be mainly attributed to an increase in TIGIT⁺ Tregs