Abecma
idecabtagene vicleucel · BCMA CAR-T12 weeks
Holoclar: how long were the pivotal tox studies?
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
Longest pivotal study
0 (no in vivo tox study)
“in vivo studies in a homologous animal model were considered by the CAT not to be necessary”
Pivotal GLP studies
No in vivo tox; in vitro karyotype, growth factor dependence and soft agar assays
“in order to investigate the proliferative capacity of the 3T3-J2 feeder cells, the applicant performed in vitro karyotype analysis and soft agar assays.”
Route in tox
Topical ocular (no animal dosing); in vitro only
“the product is intended for administration to the eye where it remains locally at the site of application”
Same question, other cell therapies
Alofisel
darvadstrocel · Allogeneic adipose MSC26 weeks
Amtagvi
lifileucel · TIL therapy0 (no in vivo tox study)
Aucatzyl
obecabtagene autoleucel · CD19 CAR-T2 weeks
Breyanzi
lisocabtagene maraleucel · CD19 CAR-T14 weeks
Carvykti
ciltacabtagene autoleucel · BCMA CAR-T14 weeks
ChondroCelect
characterised viable autologous cartilage cells · Autologous chondrocytes53 weeks
Ebvallo
tabelecleucel · EBV-specific allogeneic T cells20 weeks
Encelto
revakinagene taroretcel · CNTF (encapsulated RPE cell implant)26 weeks
Gintuit
allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts52 weeks
Kymriah
tisagenlecleucel · CD19 CAR-T31 weeks
Lantidra
donislecel · Allogeneic pancreatic islets0 (no in vivo tox study)
MACI
autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes53 weeks
Omisirge
omidubicel · Expanded cord blood HPC12 weeks
Provenge
sipuleucel-T · PAP-GM-CSF (autologous APC)6 weeks
Rethymic
allogeneic processed thymus tissue · Allogeneic thymus tissue39 weeks
Ryoncil
remestemcel-L · Allogeneic BM-MSC26 weeks
Spherox
spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids39 weeks
StrataGraft
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts20 weeks
Tecartus
brexucabtagene autoleucel · CD19 CAR-T30 weeks
Tecelra
afamitresgene autoleucel · MAGE-A4 TCR-T0 (no in vivo tox study)
Yescarta
axicabtagene ciloleucel · CD19 CAR-T30 weeks
Zalmoxis
allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells3 weeks
Zemcelpro
dorocubicel · UM171-expanded cord blood CD34+28 weeks
Laviv
azficel-T · Autologous fibroblastsNot stated in public reviews
Tregzi
allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + TconNot stated in public reviews