The invention is a method of generating regulatory T-cells from CD4+ naive T-cells in vitro without the use of added cytokines.
Regulatory T-cells (Tregs) are produce in vivo and are utilized by the body to avoid immune responses that may damage host cells and organs. Therefore, Tregs have an extremely important role in autoimmune diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), systemic lupus erythematous, as well as organ transplant rejection.
The current method allows for ex vivo production of Tregs through the isolation of CD4+ naive T-cells from a patient suffering from an applicable disorder. The novel method allows for the naive T-cells to be differentiated into Tregs. The Tregs can be further purified ex vivo and administered to the patient in an extremely pure form.
The method can be used for treating a number of autoimmune diseases such as those listed above. Further, the method can be used to decrease the likelihood of an organ recipient's immune system rejecting the organ.
The invention involves collecting the patient's CD4+ naive T-cells and incubating the cells with one or more stimulants that efficiently transform the naive cells to Treg cells. The Treg cells are further purified and administered to the patient accordingly.
Unlike current methods of treating autoimmune disorders, this method does not depend on attempting to upregulate natural Treg production or increase the number of existing Treg cells. Instead the Treg cells are generated ex vivo and readministered to the patient. This ex vivo approach offers personalized therapy while providing pure Tregs to the patient.
Ex vivo differentiation allows for the benefits of more Tregs while limiting the side effects that upregulating medications may cause.
This technology applies to autoimmune disorders as well as organ transplant rejections.