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Atlas/Cell therapy/StrataGraft/Efficacy evidence

StrataGraft: animal efficacy model or human cells?

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Check my plan vs. these
Efficacy evidence
No nonclinical pharmacology studies; efficacy claims rest on clinical data
“However, no nonclinical pharmacology studies were conducted; please refer to the clinical review memo for confirmation of these claims.”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Why that model
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reviewer's view of the efficacy data
FDA deferred efficacy claims to the clinical review; no nonclinical deficiencies and data support approval
“There are no nonclinical deficiencies identified in this submission. There are no outstanding requests for additional nonclinical data for evaluation of STRATAGRAFT®.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
NSG mice bearing subcutaneous BCMA+ human MM xenografts: dose-dependent anti-tumor activity and improved survival

Alofisel

darvadstrocel · Allogeneic adipose MSC
TNBS-induced colitis mice: dose-dependent improved survival and body weight; no anal fistula model

Amtagvi

lifileucel · TIL therapy
Published literature only: tumor-derived lymphocytes with Cy and IL-2 in murine colon adenocarcinoma and sarcoma metastasis models

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
Systemic human tumor xenograft mouse model: single IV dose of obe-cel significantly reduced tumor burden by Day 12

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
Raji Burkitt's lymphoma-bearing NOD/SCID IL-2Rγnull xenograft mice

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
Immunodeficient (NCG) mice engrafted with human multiple myeloma cells: dose-dependent anti-tumor activity and survival

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Ectopic nu/nu mouse model and orthotopic goat cartilage-defect model (ChondroCelect-like goat cells)

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
SCID mice with EBV+ BLCL-induced B cell lymphomas (IP/SC) treated with autologous tabelecleucel

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
rcd1 dog model of retinitis pigmentosa: NT-501 implant protected outer nuclear layer from photoreceptor loss

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Full-thickness wound in athymic (nude) mice grafted with Apligraf

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
No product-specific pharmacology studies; published rat LSCD studies with similar fibrin-cultured limbal cells as proof of principle

Kymriah

tisagenlecleucel · CD19 CAR-T
Mice bearing human primary pre-B ALL xenografts: CTL019 improved survival vs mock T cells

Lantidra

donislecel · Allogeneic pancreatic islets
Literature only: animal allogeneic/syngeneic islets with immunosuppressants in diabetic mice, rats and NHPs; no studies with the product

Laviv

azficel-T · Autologous fibroblasts
Literature only: animal analog fibroblasts in immunocompetent animals and human fibroblasts in immunodeficient mice; product not tested

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Analogous MACI (animal cells on same membrane) in critical-sized knee/stifle cartilage defects in rabbits and horses: improved repair vs membrane alone or empty defect

Omisirge

omidubicel · Expanded cord blood HPC
Human bone marrow engraftment of NAM-cultured cord blood cells in irradiated NOD/SCID mice; in vitro migration and phenotype assays

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Rodent surrogates: rat APCs with rPAP-rGM-CSF inducing prostate-specific inflammation; antigen-loaded APCs protecting mice against tumour challenge

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Allogeneic neonatal thymus transplanted into nude rats (engraftment, endogenous T cell development)

Ryoncil

remestemcel-L · Allogeneic BM-MSC
Human ceMSC co-cultured with allogeneic immune cells (T cell suppression, cytokine modulation); no animal GVHD model

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Immunodeficient mice (human spheroids) plus minipig pilot and 6-month Merino sheep studies with analogously produced autologous spheroids

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
Surrogate anti-murine CD19 CAR T cells in lymphodepleted syngeneic CD19+ B-cell lymphoma mice

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
Murine tumor xenograft studies showing dose-dependent tumor control

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Xenogeneic GVHD model in sub-lethally irradiated immunodeficient mice: human Tcons with human Tregs gave dose-dependent GVHD inhibition

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
Published surrogate anti-murine CD19 CAR T cells in lymphodepleted syngeneic CD19+ B-cell lymphoma mice

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Xenogeneic GvHD models in NOD/SCID mice comparing MM-TK with unmanipulated PBL

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
In vivo primary and secondary engraftment of UM171-cultured human cord blood CD34+ cells; in vitro expansion studies

Summary across all 27 cell therapies →