Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation

Exclusion Criteria

• •Donors:
• •1. Pregnant or breastfeeding
• •2. Participation in an interventional clinical trial within 30 days prior to Screening or in observation period of a competing study
• •3. Severe psychiatric disease
• •4. Severe cardiovascular diseases (i.e., heart insufficiency of grade NYHA III or IV)
• •5. Severe neurological diseases
• •6. Severe liver or kidney diseases
• •7. Any acute or chronic disease that may put the donor at risk in case of cell donation by leukapheresis
• •8. Malignant neoplasms, except in situ carcinoma after complete removal
• •9. Known infections or exposures to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus, West Nile virus (WNV; testing only required during WNV season \[June 1st to November 30th of a year\]), gonorrhea or syphilis, with the risk of transmission of infection (Note: If tested positive for EBV immunoglobulin \[Ig\]M, an EBV PCR test has to be performed for confirmation)
• •10. Active bacterial, mycotic or viral infection, except active infections that, in the investigator's opinion, do not affect patient safety (e.g., foot fungus, nail fungus, or common warts)
• •11. Known malaria infection; known infection of tuberculosis, Q fever, Salmonella typhi and paratyphi, or osteomyelitis (if not medically documented to have been cured for 2 years); known toxoplasmosis (except if symptom free for 6 months); after completion of treatment for rheumatic fever (except if treatment was completed for 2 years)
• •12. Known transmissible spongiform encephalopathies
• •13. Known protozoonosis (babesiosis, trypanosomiasis \[e.g., chagas\], leishmaniosis), known chronic bacterial infections as brucellosis, rickettsiosis, leprosy, relapsing fever, melioidosis, tularemia (except after assured healing according to documented medical assessment)
• •14. Autoimmune diseases requiring systemic immunosuppressive therapy
• •15. Allergies requiring systemic immunosuppressive therapy
• •16. Immunosuppressive therapy within 6 months prior screening
• •17. Known or suspected abuse of alcohol, drugs, or medicinal products
• •18. Unexplained night sweats, unexplained fever, unexplained weight loss, prolonged unexplained cough or diarrhea, unexplained skin lesions, lymph gland swelling or thrush
• •19. Dura mater and/or cornea grafts, allogeneic organ transplants, xenotransplants, pituitary hormones of human origin received
• •20. Stay of longer than 6 months in the United Kingdom between 1980 and 1996 and/or an operation and/or blood transfusion in the United Kingdom after 01-Jan-1980
• •21. Operations or other invasive interventions (e.g., endoscopies, biopsies, catheter applications, acupunctures \[except acupuncture with sterile and/or disposable needles\]) within 4 months prior to Screening
• •22. Any invasive exposure to blood (i.e., allogeneic blood components or plasma derivatives) or blood-contaminated injection needles or instruments, tattoos or piercings within 4 months prior to Screening
• •23. Positive PCR test result for SARS-CoV-2 at Screening
• •24. Hemoglobin \<8.0 g/dL, thrombocytes \<80,000/μL and/or leukocytes \<3,000/μL
• •25. Known history of hypersensitivity to components used in the leukapheresis setting (i.e., components of the anticoagulant acid citrate dextrose solution)
• •26. Any finding or medical condition prohibiting the inclusion in the trial according to the judgment of the responsible leukapheresis physician (including assessment of the suitability of the veins for leukapheresis by the investigator)
• •Patients:
• •1. Preexisting severe psychiatric disorder
• •2. Heart insufficiency of grade NYHA III or IV
• •3. Severe liver disease (aspartate aminotransferase or alanine aminotransferase or gamma glutamyl transpeptidase ≥3 x ULN)
• •4. Active infection of HIV, HBV, HCV, EBV or syphilis
• •5. Active bacterial, mycotic, or viral infection, except active infections that, in the investigator's opinion, do not affect patient safety (e.g., foot fungus, nail fungus, or common warts)
• •6. Negative serological test result for antibodies specific for Epstein-Barr virus (EBV) antigens (Note: EBV negative patients can be included if the donor is confirmed EBV negative)
• •7. Malignant disease within 2 years prior to Screening, except basal cell carcinomas of the skin and in situ carcinomas
• •8. Immunosuppressive therapy (e.g., for the treatment of an auto-immune disease) within 6 months prior Screening
• •9. Preexisting vasculitis or collagenosis
• •10. Known presence of irregular antibodies in Coombs test
• •11. Vaccination within 4 weeks prior to Screening
• •12. Spleen removed
• •13. Known or suspected abuse of alcohol, drugs, or medicinal products
• •14. Pregnant or breastfeeding
• •15. Female patients who have a child with the donor or were pregnant from the donor due to possible sensitization
• •16. Known history of hypersensitivity to the cellular components or to any other constituent/excipient in the pharmaceutical formulation of MIC (e.g., components of the SSP+ buffer as electrolytes (sodium chloride, potassium chloride, magnesium), citrate and phosphate, traces of mitomycin C, human albumin, or EDTA)
• •17. Any finding or medical condition prohibiting the inclusion in the trial according to the judgment of the investigator
• •18. Participation in an interventional clinical trial within 30 days prior to Screening or in observation period of a competing study
• •19. Employees of the sponsor, or employees or relatives of the investigator