One year follow-up of 12 children with Type-I diabetes, treated with autologous-expanded ex vivo Tregs. Patients received either a single or double Treg infusion up to a total dose of 30 × 106/kg. The data supported the safety of the infused Tregs, with 8/12 treated patients requiring lower requirements of insulin, with two children completely insulin independent at 1 year. The gene discussed is INS; the disease is type 1 diabetes mellitus.