Table 1.
Patient and UCB characteristics
| Patient characteristics | Cohort 1 | Cohort 2 | ||||
|---|---|---|---|---|---|---|
| Sample size (n) | 9 | 12 | ||||
| Median age, y (range) | 43.0 (29-64) | 57.5 (19-66) | ||||
| Male gender, n (%) | 4 (44.4) | 8 (66.7) | ||||
| Median weight (kg, range) | 73.8 (44.7-126) | 78.7 (48.7-149.6) | ||||
| Primary malignancy, n (%) | ||||||
| AML | 3 (33.3) | 5 (41.7) | ||||
| MDS | 2 (22.2) | 4 (33.3) | ||||
| NHL/CLL | 2 (22.2) | 3 (25.0) | ||||
| ALL | 2 (22.2) | 0 | ||||
| Prior autologous transplant, n (%) | 2 (22.2) | 2 (16.7) | ||||
| CMV seropositive, n (%) |
7 (77.8) |
7 (58.3) |
||||
|
UCB unit characteristics |
dmPGE2-UCB |
Untreated UCB |
P |
dmPGE2-UCB |
Untreated UCB |
P |
| HLA match | ||||||
| 4/6 | 8 | 8 | NS | 10 | 8 | .64 |
| 5/6 | 1 | 1 | 2 | 4 | ||
| Precryopreservation | ||||||
| TNC (×107/kg) | 3.03 | 2.53 | .43 | 2.64 | 1.95 | .02 |
| CD34+ (×105/kg) | 1.58 | 1.54 | .79 | 1.21 | 1.01 | .69 |
| Postthaw | ||||||
| TNC (×107/kg) | 2.17 | 1.8 | .45 | 1.8 | 1.7 | .43 |
| CD34+ (×105/kg) | 0.7 | 0.68 | .94 | 0.74 | 0.56 | .71 |
| CFU-GM (×103/kg) | 6.76 | 2.65 | .19 | 4.5 | 6.89 | .77 |
| First infused unit |
3 |
6 |
12 |
0 |
||
|
dmPGE2 processing |
||||||
| CD34+ cell count (%) | −20.92% | −7.87% | ||||
| TNC viability (7-AAD) | −0.27% | 1.81% | ||||
| CD34+ viability (7-AAD) | −1.40% | −1.28% | ||||
ALL, acute lymphoblastic leukemia; AML, acute myeloblastic leukemia; CMV, cytomegalovirus; GM, granulocyte-macrophages (in CFUs); MDS, myelodysplastic syndrome; NHL/CLL, non-Hodgkin lymphoma/chronic lymphocytic leukemia.