Type 1 Diabetes Mellitus — T1DM Immunotherapy Using Polyclonal Tregs + IL-2
Citation(s)
Ahmadzadeh M, Rosenberg SA IL-2 administration increases CD4+ CD25(hi) Foxp3+ regulatory T cells in cancer patients. Blood. 2006 Mar 15;107(6):2409-14. Epub 2005 Nov 22.
Ash S, Yarkoni S, Askenasy N Lymphopenia is detrimental to therapeutic approaches to type 1 diabetes using regulatory T cells. Immunol Res. 2014 Jan;58(1):101-5. doi: 10.1007/s12026-013-8476-x. Review.
Bluestone JA Regulatory T-cell therapy: is it ready for the clinic? Nat Rev Immunol. 2005 Apr;5(4):343-9. doi: 10.1038/nri1574. Review.
Buckner JH Mechanisms of impaired regulation by CD4(+)CD25(+)FOXP3(+) regulatory T cells in human autoimmune diseases. Nat Rev Immunol. 2010 Dec;10(12):849-59. doi: 10.1038/nri2889. Review.
Chatenoud L, Bluestone JA CD3-specific antibodies: a portal to the treatment of autoimmunity. Nat Rev Immunol. 2007 Aug;7(8):622-32. Epub 2007 Jul 20. Review.
Monti P, Heninger AK, Bonifacio E Differentiation, expansion, and homeostasis of autoreactive T cells in type 1 diabetes mellitus. Curr Diab Rep. 2009 Apr;9(2):113-8. Review.
Salomon B, Bluestone JA Complexities of CD28/B7: CTLA-4 costimulatory pathways in autoimmunity and transplantation. Annu Rev Immunol. 2001;19:225-52. Review.
Sitrin J, Ring A, Garcia KC, Benoist C, Mathis D Regulatory T cells control NK cells in an insulitic lesion by depriving them of IL-2. J Exp Med. 2013 Jun 3;210(6):1153-65. doi: 10.1084/jem.20122248. Epub 2013 May 6.
Tang Q, Bluestone JA Regulatory T-cell physiology and application to treat autoimmunity. Immunol Rev. 2006 Aug;212:217-37. Review.
Tang Q, Bluestone JA The Foxp3+ regulatory T cell: a jack of all trades, master of regulation. Nat Immunol. 2008 Mar;9(3):239-44. doi: 10.1038/ni1572. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.