TABLE 1.
Patient and unit characteristics in recipients of ex-vivo expanded cells.
| Characteristic | EPC (n = 15) |
|---|---|
| Female, n (%) | 7 (46) |
| Age, y, median (range) | 21 (5–45) |
| Weight, kg, median (range) | 59 (23–89) |
| Diagnosis, n (%) | |
| ALL | 8 (53) |
| AML | 6 (40) |
| MDS/CML | 1 (7) |
| Other | 0 |
| CMV seropositive, n (%) | 11 (73) |
| Race, n (%) | 6 (40) |
| Caucasian | 9 (60) |
| Non-Caucasian | |
| Disease Risk, n (%) | - |
| Low | 11 (74) |
| Intermediate | 3 (20) |
| High | 1 (6) |
| Very high | |
| MRD+, n (%) | 6 (40) |
| Follow-up, y, median (range) | 5.7 (4.4–6.2) |
| Number of unmanipulated donors, n (%) | |
| 1 | 4 (27) |
| 2 | 11 (73) |
| HLA match unmanipulated donors, n (%) a | |
| 4/6 | 9 (60) |
| 5/6 | 6 (40) |
| 6/6 | - |
| Infused Cell Doses (pre-freeze), median (range) b | |
| Total Unmanipulated TNC/kg x 107 | 6.1 (4.3–17.1) |
| Total Unmanipulated CD34/kg x 106 | 0.26 (0.08–0.98) |
| Expanded Product TNC/kg x 107 | 5.8 (2.2–10.9) |
| Expanded Product CD34/kg x 106 | 5.2 (3.1–11.6) |
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; MDS/CML, Myelodysplastic Syndrome/Chronic Myeloid Leukemia; MRD, measurable residual Disease; HLA.
a
HLA, matching reflects the lowest HLA-match of the unmanipulated unit.
b
Pre-freeze median TNC, and CD34+ of all units.