Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Table 2 Patients’ characteristics and inclusion criteria

Parameter	Inclusion criteria	Patients [validation run]
Parameter	Inclusion criteria	KD1 [#01]	KD2 [#02]	LD1 [#03]	LD2 [#04]
Age	≥ 18 years	47 years	62 years	61 years	60 years
Gender	Unconcerned	Male	Female	Male	Male
Medical condition	End-stage disease	End-stage kidney disease	End-stage kidney disease	End-stage liver disease (alcoholic cirrhosis)	End-liver liver disease
HIV1/2 (Ag/Abs)^§	Negative	Negative (4/4 patients)
Anti-HCV Abs^§	Negative	Negative (4/4 patients)
HBs Ag^§	Negative	Negative (4/4 patients)
Anti-HBc Abs^§	Negative	Negative (4/4 patients)
Anti-VDRL Abs^§	Negative	Negative (4/4 patients)
Informed consent	Signed	Signed (4/4 patients)

KD patient with kidney disease, LD patient with liver disease, Ag antigen, Abs antibodies
^§Chemiluminescent microparticle immunoassay (CMIA)

ISSN: 1479-5876