Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133⁺ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

Table 3

Summary of release data in 8 ATMP-CD133 batches.

Release test	Results				Acceptance criteria
	Mean	Standard deviation	Median	Range
Purity (%)	88.86	±6.21	90.60	81.40–96.20	≥50%
Viability (%)	99.13	±1.47	99.87	96.03–99.97	≥70%
Cellularity (×10^6)	10.37	±9.08	9.69	2.85–30.84	≥1.0 × 10^6
Sterility	Sterile (8/8 batches)				Sterile
Endotoxin	<0.5 EU/mL (8/8 batches)				<0.5 EU/mL
Mycoplasma	Absent (8/8 batches)				Absent