Parameter | Validation run | KD patients | LD patients | ||||
---|---|---|---|---|---|---|---|
#01 [KD1] | #02 [KD2] | #03 [LD1] | #04 [LD2] | Mean ± SD | Mean ± SD | ||
Starting material | Viable CD45+ cells (%) | 99.4 | 99.8 | 99.8 | 99.9 | 99.6 ± 0.3 | 99.9 ± 0.1 |
Apheresis’ processed volume (mL) | 54.4 | 69.2 | 50.8 | 54.8 | 61.8 ± 10.5 | 52.8 ± 2.8 | |
WBC concentration (× 106/mL) | 194.0 | 129.5 | 116.0 | 44.5 | 161.8 ± 45.6 | 80.3 ± 50.6 | |
Treg cells concentration (× 106/mL) | 6.32 | 3.04 | 1.98 | 0.82 | 4.7 ± 2.3 | 1.4 ± 0.8 | |
Treg cell absolute numbers (× 106) | 343.6 | 210.3 | 100.6 | 44.9 | 277.0 ± 94.3 | 72.8 ± 39.4 | |
Treg cells (%) | 2.6 | 1.8 | 1.3 | 1.6 | 2.2 ± 0.6 | 1.5 ± 0.2 | |
CD127− Treg cells (%) | na | 1.7 | 2.0 | 2.1 | 1.7 na | 2.1 ± 0.1 | |
CD45+CD8+ cells (%) | 27.2 | 34.3 | 22.2 | 25.0 | 30.8 ± 5.0 | 23.6 ± 2.0 | |
Post-enrichment fraction | Treg cells absolute numbers (× 106) | 116.7 | 91.1 | 54.4 | 41.1 | 103.8 ± 18.0 | 47.8 ± 9.4 |
Treg cells purity (%) | 84.9 | 81.3 | 53.9 | 70.6 | 83.1 ± 2.5 | 62.3 ± 11.8 | |
CD127− Treg cells (%) | 65.6 | 70.1 | 47.1 | 66.8 | 67.9 ± 3.2 | 57.0 ± 13.9 | |
FoxP3+ Treg cells (%) | 84.9 | 54.1 | 47.0 | 59.9 | 69.5 ± 21.8 | 53.5 ± 9.1 | |
CD127− FoxP3+ Treg cells (%) | 65.4 | 51.6 | 45.3 | 58.9 | 58.5 ± 9.8 | 52.1 ± 9.6 | |
CD45+ CD8+ cells (%) | 0.8 | 0.1 | 0.6 | 0.1 | 0.5 ± 0.5 | 0.4 ± 0.4 | |
Recovery (%) | 33.9 | 43.3 | 54.1 | 91.5 | 38.6 ± 6.6 | 72.8 ± 26.5 |