Table 2. Summary of product administration data.
Cell Product Type | Fresh/Cryopreserved (DMSO) | Route of Administration | Adverse Reaction | Reaction Type | ||||
---|---|---|---|---|---|---|---|---|
Yes | No | Chills | Hyper-tension | Fever | Other | |||
BM-MNCs (auto, BM-derived)a | Fresh | Intra-arterial | - | 164 | - | - | - | - |
Fresh | Direct tissue injection | - | 41 | - | - | - | - | |
Fresh | Intravenous | - | 35 | - | - | - | - | |
CD133+ progenitor cells (auto, leukapheresis) | Fresh | Intramuscular | - | 2 | - | - | - | - |
CTLs (auto, PB-derived) | Cryopreserved | Intravenous | - | 77 | - | - | - | - |
CTLs (allo, BM-derived) | Cryopreserved | Intravenous | - | 12 | - | - | - | - |
CTLs (allo, PB-derived)b | Cryopreserved | Intravenous | 8 | 112 | - | - | 3 | 5 |
DCs (auto, leukapheresis) | Cryopreserved | Other: Intra-lymph node | - | 16 | - | - | - | - |
DCs (auto, leukapheresis) | Cryopreserved | Intra-dermal | - | 33 | - | - | - | - |
HSCs (allo, UCB-derived) | Fresh | Intravenous | 5 | 24 | - | 5 | - | 4 |
MSCs (allo, BM-derived) | Fresh | Intravenous | 4 | 6 | 1 | 1 | - | 9 |
MSCs (allo, BM-derived) | Cryopreserved | Intravenous | - | 3 | - | - | - | - |
NK cells (allo, apheresis)c | Fresh | Intravenous | 26 | 26 | 16 | 9 | 5 | 34 |
NK cells (allo, UCB-derived) | Fresh | Intravenous | 9 | 7 | 8 | 1 | 3 | 3 |
NK cells (auto or allo, leukapheresis)d | Fresh | Intravenous | 1 | 4 | 1 | - | 1 | 1 |
Cryopreserved | 1 | 3 | - | - | - | 1 | ||
T regs (allo, PB-derived) | Fresh | Intravenous | - | 3 | - | - | - | - |
T regs (allo, UCB-derived)e | Fresh | Intravenous | 2 | 41 | - | 1 | - | 2 |
Total | 56 | 609 | 26 | 17 | 12 | 59 |
Source: auto = autologous; allo = allogeneic; BM-derived = bone marrow-derived; PB-derived = peripheral blood-derived; UCB-derived = umbilical cord blood-derived. Cell type: BM-MNCs = bone marrow mononuclear cells; CTLs = cytotoxic T lymphocytes; DCs = dendritic cells; MSCs = mesenchymal stem/stromal cells; NK = natural killer cells; Tregs = T regulatory cells; HSCs = hematopoietic stem cells.
Data collected from 1 single-site and 3 multi-site trials.
Data collected from 4 single-site trials, 1 multi-site trial, and from third party use under compassionate use INDs.
Data collected from 3 single-site trials.
This single-site trial performed 9 administrations and used either autologous (7) or allogeneic (2) NK cells that were administered either fresh (5) or upon thaw (4).
Data collected from 2 single-site trials.