Table 2.
Patients With Primary or Secondary Graft Failure
| Case | Patient age | Cell source | Diagnosis | Conditioning regimen | Cryopreservation location | Non-conformance | Viable CD34 recovery⁎ | Post-thaw viability of CD34+ cells† | Infused viable CD34+ cell dose (×106/kg) | Outcome |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 17 | HPC(A) | AML | Flu/Mel (RIC) + ATG | Collection center (domestic) | None | 79% | Not available | 4.37 | Primary graft failure. Alive at day 55 |
| 2 | 57 | HPC(A) | AML | Flu/Mel (RIC) + ATG | Collection center (international) | None | 64% | 74% | 4.8 | Died day 25 of infection without neutrophil recovery |
| 3 | 68 | HPC(A) | AML | Flu/Mel (RIC) + ATG | Collection center (international) | Missing labeling and processing information | 127% | 98% | 7.6 | Neutrophil recovery day 27 then secondary graft failure. |
| 4 | 69 | HPC(A) | AML | Bu/Flu (RIC) + ATG | Collection center (international) | Missing accompanying blood sample | 78% | Not available | 4.1 | Primary graft failure. Died day 174. |
| 5 | 60 | HPC(A) | AML | Flu/TBI (RIC) + ATG | Collection center (international) | Graft arrived partially thawed | 56% | Not available | 2.8 | Neutrophil recovery day 18 then secondary graft failure. |
| 6 | 49 | HPC(A) | AML | TBI + Cy (MAC) | Regional hub (international) | None | 68% | 66% | 3.2 | Neutrophil recovery day 16, then secondary graft failure. |
MAC indicates myeloablative conditioning; RIC, reduced-intensity conditioning.
⁎
Post-thaw/pre-crypreservation CD34 count.
†
Percentage of all CD34+ events in sample that are viable.