StrataGraft
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen
Species
Mouse
Longest study
20 wk
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
Athymic nude mice only (immunodeficient wound model)
“The following toxicology study was conducted to evaluate the safety profile of STRATAGRAFT® following administration in an athymic (immunodeficient) murine wound model:”
Why that species
Human cells would elicit xenogeneic response in immunocompetent animals; nude mice have reduced T-cell response
“STRATAGRAFT® is composed of human cells, thus the potential for elicitation of a xenogeneic response following administration in immune competent animals exists.”
Surrogate molecule
No surrogate; clinical human-cell construct applied to nude mice
“Strain/Breed nude mice”
Study lengthopen answer page →
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”
Skipped studiesopen answer page →
Genotoxicity
Not conducted
“No genotoxicity studies were conducted.”
Carcinogenicity
No carcinogenicity study; tumorigenicity assessed in nude mice and in vitro, no tumors
“No tumor formation was observed for the 20-week study duration.”
Reproductive & developmental
Not conducted
“No DART studies were conducted.”
Safety pharmacology
Not conducted
“No nonclinical safety pharmacology studies were conducted”
First doseopen answer page →
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
No NOAEL; no local or systemic toxicity to 140 days; wound site showed normal healing
“No test article-related findings were observed in the examined tissues.”
Risksopen answer page →
Immune & cytokine safety
Xenogeneic response possible in immunocompetent animals, so athymic mice used; no immunogenicity studies reported
“STRATAGRAFT® is composed of human cells, thus the potential for elicitation of a xenogeneic response following administration in immune competent animals exists.”
Biodistribution & persistence
No PK/cell distribution studies; clinical biopsy DNA analysis at 3 months in 85 subjects found no allogeneic DNA
“A total of 85 subjects in the Phase 1 and Phase 3 clinical trials were evaluated at 3 months for persistence of allogeneic STRATAGRAFT DNA at the treatment site.”
Modality-specific risk
Tumorigenicity of immortalized NIKS keratinocytes; no tumors in nude mice up to 421 days
“No animal exhibited evidence of tumor formation.”