Patent ID: 7722862

Claim:
A method of adoptive cellular immunotherapy, the method comprising the steps of: extracting a mixed population of T cells from a patient diagnosed with Type I diabetes or autoimmune diabetes and presenting an indication of impaired glucose homoeostasis selected from fasting plasma glucose (FPG), post-prandial glucose (PPG), and glucose tolerance (GTT); isolating from the population a subpopulation comprising >98% CD4 + CD25 + T cells (Treg cells) by negative and positive immuno-selection and cell sorting; expanding the Treg cells of the subpopulation at least 100-fold by contacting the subpopulation with effective amounts of (i) a MHC-peptide multimer ligand for TCR/CD3 wherein the peptide is a diabetes-associated autoantigen peptide and the diabetes-associated autoantigen is selected from glutamic acid decarboxylase (GAD), an islet cell autoantigen (ICA) and insulin, (ii) a multivalent antibody specific for CD28; and (iii) IL-2, wherein the effective amount of IL-2 is 200 to 2500 IU IL-2/ml, to obtain ex vivo expanded Treg cells; introducing into the patient 10 7 to 10 11 of the ex vivo expanded Treg cells; and detecting a resultant improvement in the impaired glucose homoeostasis.