Table 4. Assessment of NP dosing on human islet isolation parameters.
|
High active neutral protease (n = 10) |
Neutral protease GMP grade (n = 7) |
P | |
|---|---|---|---|
| Donor age (y) | 42.7 ± 5.2 | 37.1 ± 6.5 | 0.517 |
| Donor body mass index (kg/m2) | 25.9 ± 1.5 | 29.2 ± 1.9 | 0.192 |
|
Cold ischemia time (h) |
8.35 ± 1.6 | 7.7 ± 1.6 | 0.770 |
| Pancreas weight (g) | 82.5 ± 8.2 | 95.3 ± 3.4 | 0.175 |
|
Collagenase dose (PZ-U/g pancreas) |
32.5 ± 4.6 | 25.3 ± 2.2 | 0.182 |
|
NP dose (DMC U/g pancreas) |
1.16 ± 0.20 | 2.16 ± 0.4* | 0.038 |
|
Endotoxin load - NP only (EU) |
78.5 ± 7.1 | 602.4 ± 93.3** | 0.001 |
|
Total endotoxin load (EU) |
500.6 ± 63.8 | 826.9 ± 94.5* | 0.015 |
| Digestion time (min) | 16.6 ± 1.3 | 14.7 ± 1.4 | 0.344 |
| Undigested pancreas weight (g) | 13.3 ± 3.8 | 9.8 ± 1.4 | 0.398 |
|
Islet mass pre-purify (×103 IE) |
543 ± 56 | 607 ± 92 | 0.558 |
|
Islet mass pre-purify (IE/g pancreas) |
6,873 ± 618 | 6,382 ± 900 | 0.661 |
| Trapped (%) | 44.2 ± 6.6 | 31.7 ± 6.0 | 0.179 |
|
Purification recovery (%) |
61.7 ± 2.7 | 66.7 ± 5.5 | 0.437 |
|
Islet mass post-purify (×103 IE) |
330 ± 32 | 405 ± 70 | 0.356 |
| Purity (%) | 44.0 ± 2.5 | 50.7 ± 3.4 | 0.134 |
|
Packed cell volume (mL) |
4.5 ± 0.5 | 5.0 ± 0.7 | 0.540 |
|
Islet concentration (×103 IE/mL) |
77 ± 8 | 82 ± 11 | 0.690 |
|
Viability (%) |
83.4 ± 2.9 | 80.6 ± 3.4 | 0.549 |