Is this truly a medical breakthrough?
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Yes. YTS treatment overcame the limitations that previous studies on immunotherapy had not previously addressed through the improvement of drug target specificity (T-cells non-depleting) and prospective reductions in adverse effects. Euglycemia was achieved in the study without additional exogenous insulin, and could potentially eradicate the needs for insulin replacement therapy in diabetic patients. This opens up a possible holy grail therapy for type I diabetes in the future.
No. As a methodological and conceptual point, there are many pre-existing immunotherapies that have been studied. Immunotherapies targeting CD3 cells have reached a phase 3 clinical trial. Also, other studies on anti-CD4 and anti-CD8 monoclonal antibody to induce an immune-tolerance in allograft models have been done over the past decade by a number of researchers.
No. As a methodological and conceptual point, there are many pre-existing immunotherapies that have been studied. Immunotherapies targeting CD3 cells have reached a phase 3 clinical trial. Also, other studies on anti-CD4 and anti-CD8 monoclonal antibody to induce an immune-tolerance in allograft models have been done over the past decade by a number of researchers.
How novel?
In one of the first studies in exploring type I diabetes treatment in which the role of both CD4 and CD8 T-cells was appreciated (El-Sheikh et al, 1999), it was found that depletion of these T cells through anti-CD2 and anti-CD8 monoclonal antibodies administration in diabetes-prone rats prevented IFN-γ mRNA up-regulation in the islets, as well as decreased Interleukin-10 (IL-10) which is responsible for immune response regulation and inflammation. In other words, this early experiment demonstrates that suppressing the activities of CD4 and CD8 T-cells could protect β-cells from being destroyed through macrophage activation (due to IFN-γ) and autoimmune response (IL-10). The study essentially lays the groundwork for type 1 diabetes treatment through specific T cell targeting.
How soon do we expect to see this to become available?
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10 - 20 years. There is still a need to generate a humanised monoclonal antibody specific for CD4 and CD8. In addition, the treatment will need to undergo several phases of clinical trial and necessary modifications to ensure that it retains its efficacy as well as its non-depleting nature that is responsible for its minimum adverse effects when given to patients. This is a long, exhaustive and expensive process that can take decades before it can become available for clinical use.