Table 3. . Summary data related to the generation of dendritic cells and the final dendritic cell vaccine products.
| Cell characteristics | Single arm | Randomized | Combined |
|---|---|---|---|
| Mean number of cells obtained by apheresis (n) | 10.0 × 109 (46) |
6.7 × 109 (18) |
9.1 × 109 (64) |
| Monocytes (CD14+), % (n) | 17.3%
(54) |
17.5%
(18) |
17.4% (72) |
| Mean number of monocytes placed in culture to produce DC (n) | 2.0 × 108 (44) |
4.2 × 108 (18) |
2.6 × 108 (62) |
| CD80 positive pre co-culture with irradiated tumor cells, % (n) | 39.1%
(42) |
15.3%
(17) |
32.2%
(59) |
| CD86 positive pre co-culture with irradiated tumor cells, % (n) | 75.5%
(42) |
67.7%
(17) |
73.3%
(59) |
| CD11c positive pre co-culture with irradiated tumor cells, % (n) | 99.3%
(42) |
86.4%
(17) |
95.6%
(59) |
| Mean number irradiated tumor cells in co-culture (n) | 80 × 106 (54) |
115 × 106 (18) |
88.8 × 106 (72) |
| Mean total number of cells in co-culture (n) | 213 × 106 (54) |
165 × 106 (18) |
201 × 106 (72) |
| CD80 positive post co-culture with ITC, % (n) | 37.5%
(52) |
100%
(17) |
52.9%
(69) |
| CD86 positive post co-culture with ITC, % (n) | 71.9%
(52) |
40.3%
(17) |
64.1%
(69) |
| CD11c positive post co-culture with ITC, % (n) | 87.7%
(52) |
51.8%
(16) |
79.2%
(68) |
| Number of DC (CD11c positive) per treatment dose (n) | 17.7 × 106 (52) |
8.7 × 106 (16) |
15.6 × 106 (68) |
| Number of TC (CD11c negative) per treatment dose (n) | 2.1 × 106 (52) |
4.2 × 106 (16) |
2.6 × 106 (68) |
| Total number of cells per treatment dose (n) | 19.8 × 106 (52) |
12.9 × 106 (16) |
18.2 × 106 (68) |
DC: Dendritic cell; ITC: Irradiated tumor cell; TC: Tumor cell.