Laviv
azficel-T
Species
no relevant
Longest study
n/a
Genotox
Not conducted Not conducted
Carcinogenicity
Not conducted Not conducted
Repro
Not conducted Not conducted
First dose
Not conducted Not stated publicly
Speciesopen answer page →
Species
No preclinical or toxicology studies conducted with the product
“No preclinical studies were conducted with this product.”
Why that species
No suitable animal model for rhytids; prior human commercial experience cited instead
“The BLA states that due to this previous commercial experience in humans, and due to the lack of a”
Surrogate molecule
No product testing; only published rabbit analog-cell study reviewed (not equivalent to clinical process)
“The preparation of the rabbit analog cells used in this study did not duplicate the procedure that is used for IT preparation”
Study lengthopen answer page →
Longest pivotal study
Not stated in public reviews
Pivotal GLP studies
None; no GLP toxicology; reliance on ~1100 treated subjects of prior commercial use
“No preclinical studies were conducted with this product.”
Route in tox
Skipped studiesopen answer page →
Genotoxicity
Not conducted (autologous nature, prior human experience)
“were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”
Carcinogenicity
Not conducted (autologous, minimally manipulated); tumorigenicity listed as a gap
“were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”
Reproductive & developmental
Not conducted (autologous nature, prior human experience)
“were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”
Safety pharmacology
Not conducted (autologous nature, prior human experience)
“were not conducted by the sponsor due to the autologous nature of IT and the previous human experience.”
First doseopen answer page →
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
Not stated in public reviews
Risksopen answer page →
Immune & cytokine safety
Not stated in public reviews
Biodistribution & persistence
Not studied for IT (cell survival/migration listed as a gap); published rabbit study showed autologous fibroblast survival over 5 months
“the autologous cultured fibroblasts could survive in vivo for more than 5 months”
Modality-specific risk
Tumorigenicity/abnormal growth and tissue remodeling (scarring, keloids) not evaluated in vivo; reviewer-identified gaps
“The potential for tumorigenicity and/or other abnormal growth following in vivo administration of IT.”
Similar precedents
Holoclarautologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cellsNo relevant species · noneChondroCelectcharacterised viable autologous cartilage cells · Autologous chondrocytesOther species · 53 wkGintuitallogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblastsOther species · 52 wk