Research Article

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

Table 1

Purity and viability of CD133+ cells (%) obtained in 8 batches of ATMP-CD133.

Batch #% CD133+Cell viability
Starting materialFinal product (purity)Starting materialFinal product

PTC-CD133-0521.8796.295.83%96.03%
PTC-CD133-0553.3981.8796.83%97.70%
PTC-CD133-0680.8694.6195.27%99.87%
PTC-CD133-0851.1889.8087.67%99.91%
PTC-CD133-0900.4181.4096.62%99.75%
PTC-CD133-0980.9091.4093.62%99.95%
PTC-CD133-1091.2193.6496.28%99.97%
PTC-CD133-1160.9081.9496.29%99.86%

Mean1.3488.8694.80%99.13%
Standard deviation0.936.213.06%1.47%
Median1.0490.6096.06%99.87%
Minimum value0.4181.4087.67%96.03%
Maximum value3.3996.296.83%99.97%