Figure 1
Clinical Protocol and subjects in the Phase I safety trial: (A) Outline of the clinical trial design from initiation to one-year follow-up. Although not listed patients were given intravenous corticosteroids of 500 mg pre-operatively, and weaned to 250 mg, 125 mg and 0 mg on post-operative days 1, 2 and 3 respectively. (B) The inclusion and exclusion criteria. The target population was adult recipients of living donor renal allografts that would not require hemodialysis during the first week following renal transplantation. (C) Demographics of living donor kidney transplant recipients receiving expanded autologous Tregs. Number of Tregs received by the Subjects: 1–3: 0.5 × 109, 4–6: 1 × 109, and 7–9: 5 × 109.
