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Table 2 Patients’ characteristics and inclusion criteria

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

Parameter Inclusion criteria Patients [validation run]
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
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)
  1. KD patient with kidney disease, LD patient with liver disease, Ag antigen, Abs antibodies
  2. §Chemiluminescent microparticle immunoassay (CMIA)