Multicenter phase I/II trial of the safety of allogeneic endothelial cell implants after the creation of arteriovenous access for hemodialysis use: The V-HEALTH study

Schematic and images of sponge placement. A, Diagram of placement of two 1 × 4 × 0.3 cm sponges (arrows) adjacent to venous anastomosis and outflow segment in AVF patients. B, Diagram of placement of two 1 × 4 × 0.3 cm sponges adjacent to venous anastomosis and outflow segment (phase I and II) and one 1 × 4 × 0.3 cm sponge adjacent to arterial anastomosis (phase II) in AVG patients. C, Image of a 1 × 4 × 0.3 cm sponge used in the clinical trials. D, Image of placement around venous anastomosis and outflow vein in an AVG subject.

Phase I and phase II combined participant flow. Secondary outcome analysis for the AVG population was performed on 19 Vascugel patients in the ITT group and 14 in the mITT group; 11 placebo patients in the ITT group and eight in the mITT group. Two of the 23 Vascugel (8.7%) and two of the 11 placebo (18%) AVG were never used for dialysis during the 24-week follow-up period. Secondary outcome analysis for the AVF population was performed on 23 Vascugel patients in the ITT group and 12 in the mITT group; eight placebo patients in the ITT group and six in the mITT group. Three of the 23 Vascugel (13%) and one of the eight placebo (12.5%) AVF were never used for dialysis during the 24-week follow-up period.

AVG secondary outcome of patency analyzed using the Kaplan Meier product limit method. A, ITT primary patency; B, mITT primary patency; C, ITT assisted primary patency; D, mITT assisted primary patency. Comparison of the two treatment groups was made using the log-rank test.

AVF secondary outcome of patency analyzed using the Kaplan Meier product limit method. A, ITT primary patency; B, ITT primary anastomotic patency; C, mITT primary patency; D, mITT primary anastomotic patency. Comparison of the two treatment groups was made using the log-rank test.

Bar graph of increase in % PRA at 2, 4, 12, and 24 weeks. A, At 2 weeks, more AVG placebo patients had an elevation in class I anti-HLA antibodies compared with Vascugel patients. No statistically significant differences were observed at any of the other time points. B, Time course of PRA response in four AVG Vascugel patients (02-016, 08-009, 09-003, and 09-009) and one AVG placebo subject (02-011). Only baseline and 12-week PRA were obtained for 02-016 and therefore the complete time course could not be assessed. C, No statistically significant differences were observed between AVF placebo and Vascugel patients at any of the time points. D, Time course of PRA response in five Vascugel patients. Increases of PRA ≥30% in either AVG or AVF patients did not reach statistical significance when the two treatment groups were compared (P = .26). The presence of HLA antibodies in serum samples was determined using the LABScreen Luminex platform which utilizes a panel of color-coded micro-beads coated with purified class I or class II HLA antigens and preoptimized reagents for the detection of class I or class II HLA antibodies in human sera and the LABScan 100 flow analyzer for data acquisition and analysis.