Summary of QC release criteria data
| Purity | Phenotype | Functionality | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient | Dose | Viability (%)* | CD11c (%)‡ | HLA-DR (%)‡ | CD83 (MFI)§ | CD86 (MFI)¶ | TLR2 (MFI)** | IL-10 (pg/mL)†† | IL-12 (pg/mL)‡‡ | Sterility† | QC result |
| 1 | 1×106 | 88 | 100 | 100 | 58 | 462 | 1434 | 2364 | <50 | Pass | Pass |
| 2 | Placebo | – | – | – | – | – | – | – | – | – | – |
| 3 | 1×106 | 88 | 99.9 | 100 | 41 | 773 | 1188 | 3373 | <50 | Pass | Pass |
| 4 | 1×106 | 90 | 100 | 100 | 109 | 356 | 758 | 10 510 | <50 | Pass | Pass |
| 5 | 3×106 | 90 | 99.9 | 100 | 173 | 384 | 2085 | 2295 | <50 | Pass | Pass |
| 6 | Placebo | – | – | – | – | – | – | – | – | – | – |
| 7 | 3×106 | 96 | 100 | 99.9 | 73 | 390 | 2921 | 5164 | <50 | Pass | Pass |
| 8 | 3×106 | 96 | 100 | 100 | 61 | 1878 | 251 | 1331 | <50 | Pass | Fail |
| 9 | 3×106 | 71 | 100 | 100 | 70 | 772 | 926 | 2040 | <50 | Pass | Pass |
| 10 | 10×106 | 80 | 100 | 100 | 83 | 264 | 4276 | 2425 | <50 | Pass | Pass |
| 11 | Placebo | – | – | – | – | – | – | – | – | – | – |
| 12 | 10×106 | 79 | 100 | 100 | 62 | 464 | 1704 | 4679 | <50 | Pass | Pass |
| 13 | 10×106 | 95 | 99.8 | 100 | 135 | 320 | 1473 | 1607 | <50 | Pass | Pass |
*Viability was determined using trypan blue exclusion and expressed as percentage of total cells. To pass quality control (QC) viability had to be >70%.
†Sterility was assessed by BacT/Alert and fungal screen on day 0, day 3 and final product (day 7). To pass QC, the product had to pass sterility screening with no organisms detected.
‡CD11c and human leucocyte antigen—antigen D-related (HLA-DR) expression determined using flow cytometry and expressed as a percentage of viable cells. To pass QC, the percentage of positive cells had to be >90% for both markers.
§CD83 expression determined using flow cytometry and expressed as a median fluorescence intensity (MFI) of viable cells. To pass QC, CD83 MFI had to be <350.
¶CD86 expression determined using flow cytometry and expressed as a MFI of viable cells. To pass QC, CD86 MFI had to be <1500.
**Toll-like receptor (TLR)2 expression determined using flow cytometry and expressed as a MFI of viable cells. For information only. Positive result=TLR2 MFI >200.
††Interleukin (IL)-10 levels in supernatant from the 7 days culture were determined by ELISA. To pass QC, IL-10 levels had to be >1000 pg/mL.
‡‡IL-12 levels in supernatant from the 7 days culture were determined by ELISA. To pass QC, IL-12 levels had to be <50 pg/mL.