ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants

Inclusion criteria

• Recipient age ≥30 and less than 70 years old.
• Donor age ≥18 and ≤ 70 years old.
• Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.
• Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.
• Donors will be screened and tested for HIV-1 (antigen and nucleic acid), HIV-2, hepatitis B virus (HBV, nucleic acid and surface and core antigen), hepatitis C virus (HCV, antigen and nucleic acid), Treponema pallidum (syphilis), West Nile Virus (WNV), and CJD (screening only). and tested for human T-lymphotropic virus types 1 and 2 (HTLV-1, HTLV-2) and CMV, in accordance with established UNOS guidelines for solid organ donors.
• Donors and recipients who test negative for TB using QuantiFERON gold assay.
• Must be willing and able to comply with protocol-required visit schedule and visit requirement.
• Patients who are single-organ recipients (kidney only).
• Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period. Both male and female transplant recipients must agree to the use of highly effective birth control for 12 months following ECP-DL procedure. Individuals unwilling to do so will be excluded from study participation.
• Subjects are able to understand the consent form and give written informed consent.

Exclusion criteria

RECIPIENT

• Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.
• Aphakia.
• Has undergone splenectomy
• Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism
• Patient with significant or active infection.
• Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
• Patients with PRA >80%
• Patients with current or historic donor specific antibodies
• Body Mass Index (BMI) of < 18 or > 40
• Patients who are pregnant or nursing mothers
• Patients whose life expectancy is severely limited by diseases other than renal disease
• Ongoing active substance abuse, drug or alcohol
• Major ongoing psychiatric illness or recent history of noncompliance
• Significant cardiovascular disease
• Malignancy within 3 years, excluding nonmelanoma skin cancers
• Subjects with cerebrovascular vascular disease with recent (< 6 months) stroke
• Serologic evidence of infection with HIV or HBVs Ag positive
• Recipient is EBV serologic negative
• Donor CMV serologic positive to recipient CMV serologic negative
• Recipient tests positive for HCV viral load by PCR
• Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglyceride > 400 mg/dl; total cholesterol > 300 mg/dl
• Investigational drug within 30 days prior to transplant surgery
• Anti-T cell therapy within 30 days prior to transplant surgery
• Documented severe liver disease, defined as bridging fibrosis or cirrhosis on liver biopsy
• Poorly controlled diabetes, defined as HbA1c of > 8.0
• PT/INR > 2.0
• SBP < 90 or > 180mm Hg, HR > 120 or <50bpm, Temp > 99.5F on day of proposed ECP-DL procedure
• Patients receiving concomitant enteral or topical medical therapy with potentially photosensitizing effects

DONOR

• Lack of possible peripheral IV access (two access sites)
• Has undergone splenectomy
• Donor tests positive for HCV viral load by PCR
• PT/INR > 2.0; or known hyper or hypo coagulable disorders
• Hgb < 10.0
• platelet count < 100,000
• SBP < 90 or > 160mm Hg, HR > 120 or <50bpm, Temp > 99.5F on day of proposed ECP-DL procedure
• Donors who cannot tolerate extracorporeal volume during PBMC collection