Yamanaka Factors (OSKM)
OSKM 1:1:1:0.4
Oct4 (Pou5f1) - Master Pluripotency
0.85
Sox2 - Chromatin Pioneer
0.80
Klf4 - Proliferation & Epigenetic Primer
0.75
c-Myc - Metabolic Accelerant (Oncogene)
0.40
Epigenetic & Morphogen Pulsing
HDAC / DNA Methyltransferase Inhibitor (VPA/5-aza)
0.60
Gene Network Expression
State: Somatic Fibroblast (Day 0)
Day: 0.0 / 28.0
Directed Clinical Differentiation
12%
Pluripotency Score
Closed
Chromatin State
0%
Target Purity
98.4%
Cell Viability
Clinical Translation Safety Suite
GMP QA
Teratoma Clearance
CLEAR (<0.001%)
Residual undifferentiated iPSC eradication
c-Myc Oncogenic Risk
LOW RISK
Transgene silencing & genomic integration
CNV & Karyotype Fidelity
NORMAL (46,XX)
Aneuploidy & 20q11.21 duplication assay
Epigenetic Memory Reset
RESET (94%)
CpG methylation of somatic promoters
Phase I/II Clinical Trial Dossier
Target Indication:
AMD (Subretinal RPE Sheet)
Reprogramming Method:
Sendai / Episomal Non-Integrating
Sterility & Mycoplasma:
PASS (Negative)
Regulatory Verdict:
QUALIFIED FOR HUMAN TRIAL