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Precedia/Cell therapy/ChondroCelect/Skipped studies

ChondroCelect: genotox, carcinogenicity and repro: done or skipped?

characterised viable autologous cartilage cells · Autologous chondrocytes
Check my plan vs. these
Genotoxicity
Not conducted (per cell-based product guideline)
“The omission of genotoxicity studies in the development program for ChondroCelect is in line with EMEA/CHMP/410869/2006.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Carcinogenicity
Not conducted; in vitro serial passaging senescence study instead
“In view of these results, the absence of standard carcinogenicity studies was considered to be acceptable.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Instead of carcinogenicity
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.
Instead of genotoxicity
Not applicable: cells not genetically modified
“The omission of genotoxicity studies in the development program for ChondroCelect is in line with EMEA/CHMP/410869/2006.”
✓ VerifiedEMA assessment report, p. 12Source ↗
DRG histopathology
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.
Reproductive & developmental
Not conducted; risk considered negligible
“the omission of reproductive and developmental toxicity studies in the development program for ChondroCelect is acceptable”
✓ VerifiedEMA assessment report, p. 12Source ↗
Safety pharmacology
Not conducted; locally administered cells
“the omission of safety pharmacological studies is in line with the guideline on human cell based medicinal products (EMEA/CHMP/410869/2006).”
✓ VerifiedEMA assessment report, p. 11Source ↗
Genotox: Ames
Not conducted (EMEA/CHMP/410869/2006)
“The omission of genotoxicity studies in the development program for ChondroCelect is in line with EMEA/CHMP/410869/2006.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Genotox: in vitro mammalian
Not conducted (EMEA/CHMP/410869/2006)
“The omission of genotoxicity studies in the development program for ChondroCelect is in line with EMEA/CHMP/410869/2006.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Genotox: in vivo
Not conducted (EMEA/CHMP/410869/2006)
“The omission of genotoxicity studies in the development program for ChondroCelect is in line with EMEA/CHMP/410869/2006.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Carcinogenicity model
Not conducted; in vitro senescence study of serially passaged human chondrocytes
“In order to address the carcinogenic potential of ChondroCelect, the Applicant performed an in vitro study to evaluate senescence of human articular chondrocytes after serial passaging, using ChondroCelect culture conditions.”
✓ VerifiedEMA assessment report, p. 12Source ↗
Carcinogenicity timing
Not required (absence of standard studies accepted)
“In view of these results, the absence of standard carcinogenicity studies was considered to be acceptable.”
✓ VerifiedEMA assessment report, p. 12Source ↗
hERG / QT
Not conducted (locally administered cells; per EMEA/CHMP/410869/2006)
“the omission of safety pharmacological studies is in line with the guideline on human cell based medicinal products (EMEA/CHMP/410869/2006).”
✓ VerifiedEMA assessment report, p. 11Source ↗

Email me this as a cited memo

Skipped studies for ChondroCelect, each with the regulator's own words, the page and a link. Ready to paste into a briefing document or send to your team.

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
Not conducted (traditional); insertion site analysis of 20 clinical lots

Alofisel

darvadstrocel · Allogeneic adipose MSC
Not conducted; cell-based product does not interact with DNA

Amtagvi

lifileucel · TIL therapy
Not conducted (not warranted given product characteristics and biological activity)

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
Not conducted (third-generation SIN lentiviral vector, release criterion, long-term clinical monitoring for insertional mutagenesis)

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
Not conducted (traditional); lentiviral integration site mapping instead

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
Not conducted (classical); lentiviral integration site analysis instead

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
Not conducted (ICH S6(R1)); non-genetically engineered cells

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
Done: ISO-10993 battery (bacterial, mammalian cell, mouse micronucleus on device extracts), negative

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted (nature of product and clinical experience)

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
Not conducted (classical); in vitro karyotype analysis of cells

Kymriah

tisagenlecleucel · CD19 CAR-T
Not conducted (classical); lentiviral integration site analysis on 14 donor products

Lantidra

donislecel · Allogeneic pancreatic islets
Not conducted

Laviv

azficel-T · Autologous fibroblasts
Not conducted (autologous nature, prior human experience)

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Not conducted on cells; four studies on collagen membrane were non-mutagenic

Omisirge

omidubicel · Expanded cord blood HPC
No standard genotox; cytogenetic/karyotype analyses of CF and NF showed no clonal aneuploidy

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Not conducted (autologous nature of product)

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Not conducted

Ryoncil

remestemcel-L · Allogeneic BM-MSC
Not conducted (not warranted)

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Not conducted (per cell-based product guideline)

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
Not conducted (traditional); vector integration site analysis performed instead

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
Not conducted (no test models or relevant species); integration site analysis showed polyclonal products, no selective insertion

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Not conducted

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
Not conducted; literature review of retroviral-transduced T-cell transformation risk instead

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Not conducted; in vitro retroviral integration site analysis instead

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
Done for residual UM171 only (Ames, CHO micronucleus negative) plus cytogenetics of treated cells; none for cells

Summary across all 27 cell therapies →