Table 2. Summary of product administration data.
Each row represents cell product data collected from a unique PACT approved project or clinical trial having the unique attributes of cell product type, administration of fresh or cryopreserved cells, and route of administration unless as otherwise footnoted below. Data from the 3 most common post-administration adverse reaction types are provided separately and all others were grouped together. The product source is indicated in parentheses.
| 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.