MESENCHYMAL STROMAL CELLS FOR TREATING RHEUMATOID ARTHRITIS
The present invention provides a method for treating rheumatoid arthritis comprising the use of mesenchymal stromal cells.
1 . A composition comprising mesenchymal stromal cells (MSCs) for treating rheumatoid arthritis in a subject.
2 . (canceled)
3 . A method of treating rheumatoid arthritis in a subject, comprising administering a composition comprising mesenchymal stromal cells to the subject.
4 . The method of claim 3 , wherein the rheumatoid arthritis is moderate rheumatoid arthritis having a DAS28 score of >3.2 to ≦5.1, a CDAI score of >10 to ≦22 and/or a RAPID3 score of >6 to ≦12.
5 . The method of claim 3 , wherein the rheumatoid arthritis is severe rheumatoid arthritis having a DAS28 score of >5.1, a CDAI score of >22 and/or a RAPID3 score of >12.
6 . The method of claim 3 , wherein the subject is treated during an acute phase of the rheumatoid arthritis and/or wherein the subject is first treated at not more than about 6 months from first diagnosis or onset of rheumatoid arthritis symptoms.
7 . The method of claim 3 , wherein the MSCs are administered to the subject repeatedly, optionally at weekly intervals.
8 . The method of claim 3 , wherein at least three doses of MSCs are administered to the subject.
9 . The method of claim 3 , wherein the subject is treatment refractory to methotrexate.
10 . The method of claim 7 , wherein the subject is treatment refractory to a further DMARD.
11 . The method of claim 8 , wherein the further DMARD is cyclosporine.
12 . The method according to claim 3 , wherein the mesenchymal stromal cells are adipose tissue-derived stromal cells, expanded mesenchymal stromal cells, or expanded adipose tissue-derived stromal cells.
13 . The method according to claim 3 , wherein the MSCs are allogeneic.
14 . The method according to claim 3 wherein the composition comprises between about 0.25×10 6 cells/kg to about 5×10 6 cells/kg of subject weight.
15 . The method according to claim 3 , wherein at least about 50% of the MSCs express one or more of the markers CD9, CD10, CD13, CD29, CD44, CD49A, CD51, CD54, CD55, CD58, CD59, CD90 and CD105.
16 . The method according to claim 3 , wherein at least about 50% of the MSCs do not express the markers Factor VIII, alpha-actin, desmin, S-100, keratin, CD11b, CD11c, CD14, CD45, HLAII, CD31, CD34, CD45, STRO-1 and CD133.
17 . The method according to claim 3 , wherein the MSCs are administered in a pharmaceutically acceptable carrier and/or a diluent.
18 . The method according to claim 3 , wherein the MSCs are administered systemically.
19 . The method according to claim 3 wherein the MSCs are administered via the intravenous, intralymphatic, subcutaneous, intracutaneous, intramuscular, intraarticular, intrasynovial, intrasternal, intrathecal, intralesional, or intracranial route.
20 . The method according to claim 3 , wherein the MSCs are administered in conjunction with one or more further therapeutic agents.
21 . The method of claim 3 , wherein the MSCs are cryopreserved.