Abecma
idecabtagene vicleucel · BCMA CAR-T12 weeks
StrataGraft: how long were the pivotal tox studies?
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Longest pivotal study
20 weeks
“no apparent local or systemic toxicity was observed out to 140 days following topical application of STRATAGRAFT® to immunodeficient mice with an existing wound.”
Pivotal GLP studies
Non-GLP 8+ week subchronic study NCREP.001 in 26 nude mice, single topical application, sacrificed to 140 days; retrospective tumorigenicity analyses to 421 days
“Minimum Eight Week Transdermal Subchronic Toxicity Study with STRATAGRAFT® Skin Tissue in Nude Mice”
Route in tox
Topical application on full-thickness wound bed (single administration)
“Route of Administration (ROA) Topical application on the wound bed”
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
Holoclar
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells0 (no in vivo tox study)
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
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