Cell doses and proportions at the various steps of processing
| Product . | Absolute TNC donor UCB unit . | Postimmunomagnetic separation . | Post-expansion . | Target Treg cell dose (× 106 cells/kg) . | Actual Treg dose (× 106 cells/kg) . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Absolute TNC . | Percent TNC recovery . | Absolute CD4+ CD25+ . | Proportion of CD4+ CD25+ . | Fold expansion . | Absolute TNC . | Proportion of CD4+ CD25+ . | Absolute CD4+ CD25+ . | Proportion of CD4+ Foxp3+ CD127low . | ||||
| Infused products | ||||||||||||
| 1 | 1.15E+09 | 1.50E+06 | 0.13% | 4.35E+05 | 29% | 27183 | 4.08E+10 | 94% | 3.84E+10 | 83% | 3 | 3 |
| 2 | 1.06E+09 | 1.76E+06 | 0.17% | 1.55E+06 | 88% | 24213 | 4.26E+10 | 97% | 4.13E+10 | 83% | 3 | 3 |
| 3* | 1.10E+09 | 2.25E+06 | 0.20% | 2.05E+06 | 91% | 16365 | 3.68E+10 | 98% | 3.61E+10 | 81% | 10 | 10 |
| 4† | 1.02E+09 | 1.02E+06 | 0.10% | 9.15E+05 | 90% | 6951 | 6.10E+09 | 96% | 5.86E+09 | 86% | 30 | 30 |
| 5‡ | 9.10E+08 | 7.05E+05 | 0.08% | 4.63E+05 | 67% | 1352 | 9.46E+08 | 97% | 9.18E+08 | 82% | 100 | 10 |
| 6†‡ | 1.18E+09 | 4.81E+05 | 0.04% | 3.75E+05 | 78% | 4601 | 1.88E+09 | 97% | 1.82E+09 | 91% | 100 | 10 |
| 7‡ | 1.83E+09 | 8.00E+05 | 0.04% | 7.23E+05 | 90% | 5271 | 2.45E+09 | 91% | 2.23E+09 | 89% | 100 | 10 |
| 8 | 2.47E+09 | 7.92E+06 | 0.32% | 7.61E+06 | 96% | 16897 | 1.11E+10 | 88% | 9.77E+09 | 95% | 100 | 100 |
| 9 | 2.15E+09 | 8.91E+06 | 0.41% | 7.44E+06 | 84% | 13581 | 2.41E+10 | 95% | 2.29E+10 | 90% | 100 | 100 |
| 10 | 2.07E+09 | 1.08E+07 | 0.52% | 2.82E+06 | 26% | 13550 | 2.05E+10 | 98% | 2.01E+10 | 91% | 100 | 100 |
| 11 | 1.55E+09 | 3.96E+06 | 0.26% | 3.40E+06 | 86% | 17127 | 2.25E+10 | 99% | 2.23E+10 | 91% | 100 | 100 |
| Non-infused products | ||||||||||||
| 12‡ | 1.19E+09 | 5.60E+05 | 0.05% | 2.44E+05 | 44% | 174 | 9.77E+07 | NA | NA | NA | 3 | NA |
| 13‡ | 1.18E+09 | 1.16E+06 | 0.10% | 1.05E+06 | 90% | 246 | 2.30E+08 | 95% | 2.19E+08 | NA | 100 | NA |
| Product . | Absolute TNC donor UCB unit . | Postimmunomagnetic separation . | Post-expansion . | Target Treg cell dose (× 106 cells/kg) . | Actual Treg dose (× 106 cells/kg) . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Absolute TNC . | Percent TNC recovery . | Absolute CD4+ CD25+ . | Proportion of CD4+ CD25+ . | Fold expansion . | Absolute TNC . | Proportion of CD4+ CD25+ . | Absolute CD4+ CD25+ . | Proportion of CD4+ Foxp3+ CD127low . | ||||
| Infused products | ||||||||||||
| 1 | 1.15E+09 | 1.50E+06 | 0.13% | 4.35E+05 | 29% | 27183 | 4.08E+10 | 94% | 3.84E+10 | 83% | 3 | 3 |
| 2 | 1.06E+09 | 1.76E+06 | 0.17% | 1.55E+06 | 88% | 24213 | 4.26E+10 | 97% | 4.13E+10 | 83% | 3 | 3 |
| 3* | 1.10E+09 | 2.25E+06 | 0.20% | 2.05E+06 | 91% | 16365 | 3.68E+10 | 98% | 3.61E+10 | 81% | 10 | 10 |
| 4† | 1.02E+09 | 1.02E+06 | 0.10% | 9.15E+05 | 90% | 6951 | 6.10E+09 | 96% | 5.86E+09 | 86% | 30 | 30 |
| 5‡ | 9.10E+08 | 7.05E+05 | 0.08% | 4.63E+05 | 67% | 1352 | 9.46E+08 | 97% | 9.18E+08 | 82% | 100 | 10 |
| 6†‡ | 1.18E+09 | 4.81E+05 | 0.04% | 3.75E+05 | 78% | 4601 | 1.88E+09 | 97% | 1.82E+09 | 91% | 100 | 10 |
| 7‡ | 1.83E+09 | 8.00E+05 | 0.04% | 7.23E+05 | 90% | 5271 | 2.45E+09 | 91% | 2.23E+09 | 89% | 100 | 10 |
| 8 | 2.47E+09 | 7.92E+06 | 0.32% | 7.61E+06 | 96% | 16897 | 1.11E+10 | 88% | 9.77E+09 | 95% | 100 | 100 |
| 9 | 2.15E+09 | 8.91E+06 | 0.41% | 7.44E+06 | 84% | 13581 | 2.41E+10 | 95% | 2.29E+10 | 90% | 100 | 100 |
| 10 | 2.07E+09 | 1.08E+07 | 0.52% | 2.82E+06 | 26% | 13550 | 2.05E+10 | 98% | 2.01E+10 | 91% | 100 | 100 |
| 11 | 1.55E+09 | 3.96E+06 | 0.26% | 3.40E+06 | 86% | 17127 | 2.25E+10 | 99% | 2.23E+10 | 91% | 100 | 100 |
| Non-infused products | ||||||||||||
| 12‡ | 1.19E+09 | 5.60E+05 | 0.05% | 2.44E+05 | 44% | 174 | 9.77E+07 | NA | NA | NA | 3 | NA |
| 13‡ | 1.18E+09 | 1.16E+06 | 0.10% | 1.05E+06 | 90% | 246 | 2.30E+08 | 95% | 2.19E+08 | NA | 100 | NA |
TNC, total nucleated cells; UCB, umbilical cord blood.
This was the only product that was cryopreserved and posteriorly thawed and infused.
These two were the patients who developed acute GVHD. Patient 4 had the skin rash and patient 6 presented with late acute GVHD of the gastrointestinal tract.
These products failed to achieve the target cell dose level.