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

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