Study of an Autologous Neo-Kidney Augment in Patients With Chronic Kidney Disease

Exclusion Criteria

• •1. Type 1 diabetes mellitus (DM).
• •2. History of a renal transplant.
• •3. HbA1c ≥ 104 mmol/mol IFCC at Screening.
• •4. BMI \<18.5 kg/m2 or \>35 kg/m2 at Screening.
• •5. Abnormal coagulation status as measured by APTT, INR, fibrinogen and/or platelet count.
• •6. Ineligible for an MRI or renal scintigraphy (e.g. due to hypersensitivity or allergy) study based on the Karolinska University Hospital guidelines.
• •7. Clinically significant infection requiring parenteral antibiotics within 6 weeks of biopsy or implantation.
• •8. CKD due to polycystic kidney disease, other renal structural abnormalities, myeloma kidney, history of nephroblastoma, post-streptococcal glomerulonephritis, pre- or postrenal component of CKD, and genetically based renal disease (e.g. Podocin mutations, renal agenesis).
• •9. Patients with small (\< 10 cm) kidneys or only one kidney; patients with a history of highly echogenic kidneys. Patients with an average width of kidney cortex \< 1.0 cm as estimated by MRI. Patients whose left kidney would not be acceptable for biopsy/implant as assessed by the Investigator based on results from screening procedures.
• •10. Female subjects who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using a highly effective method of birth control (including sexual abstinence). A highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects must be willing to continue birth control methods throughout the course of the study.
• •11. History of cancer within the past 5 years (excluding non-melanoma skin cancer and carcinoma in situ of the cervix) or a condition highly likely to transform into malignancy during the course of the study.
• •12. Life expectancy of less than 2 years.
• •13. Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of animal (bovine, porcine) origin or anesthetic agents.
• •14. Positive results for any of the following (per Commission Directive 2006/17/EC) at Screening and Biopsy:
• •1. Viral Nucleic Acid Testing: Human Immunodeficiency Virus (HIV) 1 and 2 RNA, Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA
• •2. Viral Protein Testing: HBV surface antigen (HBsAg)
• •3. Viral Antibody Testing: Anti-HIV 1 and 2, Anti-HBV core antigen (Anti HBc), Anti-HCV antibody.
• •4. Confirmed active infection with Treponema pallidum.
• •15. Subjects with active tuberculosis (TB) requiring treatment in the past 3 years.
• •16. Immunocompromised subjects or patients receiving immunosuppressive agents (including patients treated for chronic glomerulonephritis) within 3 months of biopsy. \[Note: inhaled corticosteroids and chronic low-dose corticosteroids \[≤ 7.5mg per day\] are permitted as are brief pulsed corticosteroids for intermittent symptoms (e.g. asthma).\]
• •17. Subjects with uncontrolled diabetes (defined as metabolically unstable by the PI), incapacitating cardiac and/or pulmonary disorders.
• •18. History of active alcohol and/or drug abuse that in the investigator's assessment would impair the subject's ability to comply with the protocol.
• •19. Subjects with an albumin value \< 25 g/L, and albumin/creatinine ratio greater than 3500mg/g at Screening or prior to Biopsy.
• •20. Patients with clinically significant hepatic disease (ALAT or ASAT \> 5.0 x ULN) at Screening.
• •21. Patients with bleeding disorders or patients taking Coumarins (e.g.,Warfarin).
• •22. Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.
• •23. Use of any investigational product (drug, biologic, or device) within 5 half-lives (drug, biologic) or 3 months, whichever is longer, without receiving prior written consent of the Medical Monitor.-