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US 10,746,729 B2Granted
Biomarkers for determining the clinical response to cell therapy
AssigneeTiGenix, S.A.U.
InventorsOlga De La Rosa, Wilfried Dalemans
Life of this patent
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Abstract
The invention relates to a method for predicting the clinical response to a therapy based on the administration of mesenchymal stem cells (MSCs) in a patient suffering from an immune-mediated inflammatory disease. The invention also relates to methods of personalised medicine as well as to therapeutic uses of MSCs in a patient suffering from an immune-mediated inflammatory disease.
Claims17
A method for selecting and treating a patient suffering from an immune-mediated inflammatory disease, the method comprising:
- (a) obtaining a blood sample from a patient;
- (b) determining in said sample from the patient at least one parameter selected from the group consisting of:
- (i) the level of monocytes,
- (ii) the level of Treg cells,
- (iii) the ratio of CD4+ T cells to Treg cells (CD4+/Treg), and
- (iv) the T cell proliferation capacity,
- (c) comparing the parameters in said sample with their reference values;
- (d) selecting a patient as likely to show a clinical response to a therapy comprising the administration of mesenchymal stem cells (MSCs) wherein the patient has at least one parameter selected from the group consisting of:
- an increased level of monocytes in said sample with respect to a reference value, wherein the reference value is obtained from the value of the level of monocytes in a blood sample from one or more patients who do not respond to a therapy based on comprising the administration of MSCs,
- a decreased level of Treg cells with respect to a reference value, wherein the reference value is obtained from the value of the level of Treg cells in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs,
- an increased ratio of CD4+ T cells to Treg cells (CD4+/Treg) with respect to a reference value, wherein the reference value is obtained from the value of the ratio of CD4+ T cells to Treg cells (CD4+/Treg) in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs, and
- an increased T cell proliferation capacity with respect to a reference value,
- wherein the reference value is obtained from the value of the T cell proliferation capacity in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs;
- and
- (e) administering a therapy comprising the administration of MSCs to the patient selected in step (d) as likely to show a clinical response to the therapy.
12 more elements
A method for the treatment of an immune-mediated inflammatory disease in a patient in need thereof, the method comprising the steps of:
- (a) selecting a patient having at least one parameter selected from the group consisting of:
- an increased level of monocytes with respect to a reference value, wherein the reference value is obtained from the value of the level of monocytes in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs,
- a decreased level of Treg cells with respect to a reference value, wherein the reference value is obtained from the value of the level of Treg cells in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs,
- an increased CD4+/Treg ratio with respect to a reference value, wherein the reference value is obtained from the value of the ratio of CD4+ T cells to Treg cells (CD4+/Treg) in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs, and
- an increased T cell proliferation capacity with respect to a reference value, wherein the reference value is obtained from the value of the T cell proliferation capacity in a blood sample from one or more patients who do not respond to a therapy comprising the administration of MSCs;
- and
- (b) administering MSCs to the patient selected in step (a).
4 more elements
Dependencies are inferred from the claim text.