Granted Patent B2

US 12,702,683 · App. 17/420,325 · Granted Aug 11, 2026

Inventor: Silviu Itescu (Melbourne, AU)

Assignee: Mesoblast International Sárl

A61K35/28A61K9/0019A61K9/0048A61P27/10

Abstract

Claims (15)

1 . A method of improving visual acuity in a human subject suffering from an ocular disease, the method comprising administering to the subject a composition comprising mesenchymal lineage precursor or stem cells (MLPSCs) in an amount sufficient to improve visual acuity as measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), wherein the ocular disease comprises degradation or inflammation of the optic nerve, and wherein treatment with an anti-VEGF agent has reduced neovascularisation in the optic tissue of the subject prior to the administration of the MLPSCs.

2 . The method of claim 1 , wherein the subject has been treated with a monthly dosage of the anti-VEGF agent for least 3 months prior to the administration of the MLPSCs.

3 . The method of claim 1 , wherein the anti-VEGF agent is an anti-VEGF antibody or fragment thereof.

4 . The method of claim 1 , wherein the mesenchymal lineage precursor or stem cells were isolated by immunoselection prior to the administration.

5 . The method of claim 4 , wherein the immunoselected cells were culture expanded prior to the administration.

6 . The method of claim 1 , wherein the mesenchymal lineage precursor or stem cells are culture expanded mesenchymal stem cells.

7 . The method of claim 1 , wherein the MLPSCs are administered to the subject at a dose of less than 350,000 cells, or less than 250,000 cells, or less than 100,000 cells, or less than 95,000 cells, or less than 90,000 cells or less than 80,000 cells, or less than 75,000 cells, or less than 70,000 cells.

8 . The method of claim 1 , wherein the MLPSCs are administered to the subject at a dose of less than 100,000 cells per mL of vitreous humor, or less than 75,000 cells per mL of vitreous humor, or less than 50,000 cells per mL of vitreous humor, or less than 25,000 cells per mL of vitreous humor, less than 20,000 cells per mL of vitreous humor.

9 . The method of claim 1 , wherein the MLPSCs are administered to the subject at a dose of about 24,500 mesenchymal precursor cells (MPCs) per mL of vitreous humor.

10 . The method of claim 1 , wherein the MLPSCs are administered as a single dose.

11 . The method of claim 1 , wherein the MLPSCs are administered intravitreally.

12 . The method of claim 1 , wherein the administration of the MLPSCs results in at least a 10-point improvement from baseline in composite NEI VFQ-25 score within at least a 6 month period.

13 . The method of claim 1 , wherein the administration of the MLPSCs results in at least a 10-point improvement from baseline in composite NEI VFQ-25 score that is maintained for at least a 3 month period.

14 . The method of claim 1 , wherein the ocular disease is neovascular AMD.

15 . The method of claim 2 , wherein the MLPSCs are administered at least one month after the 3 monthly doses of the anti-VEGF agent.

Assignments (3)

Continuity (2)

References Cited (197)