Granted Patent
B2
US 12,410,405 · App. 18/331,353 · Granted Sep 9, 2025
Enhanced MSC preparations
Inventors:
Samson Tom (Basking Ridge, NJ); Christopher Ton (Lansdale, PA); Alla Danilkovitch (Columbia, MD)
Assignee:
Mesoblast International Sàrl
C12N5/0663A61K35/28A61K41/0038A61K41/0052A61K47/6901A61K49/0423A61K49/1827A61P37/06B82Y5/00A61K2035/122A61M37/00C12N2511/00
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Abstract
The present invention provides preparations of MSCs with important therapeutic potential. The MSC cells are non-primary cells with an antigen profile comprising less than about 1.25% CD45+ cells (or less than about 0.75% CD45+), at least about 95% CD105+ cells, and at least about 95% CD166+ cells. Optionally, MSCs of the present preparations are isogenic and can be expanded ex vivo and cryopreserved and thawed, yet maintain a stable and uniform phenotype. Methods are taught here of expanding these MSCs to produce a clinical scale therapeutic preparations and medical uses thereof.
Claims (26)
1. A mesenchymal stem cell (MSC) preparation comprising:
cultured human bone-marrow-derived MSCs expanded from a cryopreserved in-process intermediate MSC preparation; wherein the cultured human bone-marrow-derived MSCs
(a) have an antigen profile comprising:
i. less than 0.75% CD45+ cells;
ii. at least 95% CD105+ cells; and
iii. at least 95% CD166+ cells; and
(b) are capable of inhibiting IL2Rα expression by CD3/CD28-activated PBMCs by at least 30% relative to a control.
2. The MSC preparation of claim 1 , wherein the MSCs express at least 13 pg TNFR1 per million MSCs.
3. The MSC preparation of claim 1 , wherein the MSCs express at least 108 pg TNFR1 per million MSCs.
4. The MSC preparation of claim 1 , wherein the MSCs express about 13 pg to about 179 pg TNFR1 per million MSCs.
5. The MSC preparation of claim 1 , wherein the MSCs express 108 pg to 368 pg TNFR1 per million MSCs.
6. The MSC preparation of claim 1 , wherein the MSCs express TNFR1 at a minimum of 272 pg/mL and a maximum of 1471 pg/mL.
7. A frozen cell suspension composition comprising:
(a) cultured human bone-marrow-derived MSCs expanded from a cryopreserved in-process intermediate MSC preparation with an antigen profile comprising: i. less than 0.75% CD45+ cells; ii. at least 95% CD105+ cells; and iii. at least 95% CD166+ cells; wherein the cultured human bone-marrow-derived MSCs are capable of inhibiting IL2Ra expression by CD3/CD28-activated PBMCs by at least 30% relative to a control;
(b) an electrolyte solution,
(c) 5% human serum albumin, and
(d) 10% DMSO.
8. A method of treating steroid refractory acute Graft versus Host Disease (aGvHD) in a pediatric patient comprising intravenously administering eight biweekly therapeutic doses of 2×10 6 mesenchymal stem cells/kg.
9. The method of claim 8 , wherein the MSCs express at least 13 pg TNFR1 per million MSCs.
10. The method of claim 8 , wherein the MSCs express at least 108 pg TNFR1 per million MSCs.
11. The method of claim 8 , wherein the MSCs express about 13 pg to about 179 pg TNFR1 per million MSCs.
12. The method of claim 8 , wherein the MSCs express about 13 pg to about 44 pg TNFR1 per million MSCs.
13. The method of claim 8 , wherein the MSCs express 108 pg to 368 pg TNFR1 per million MSCs.
14. The method of claim 8 , wherein the MSCs express TNFR1 at a minimum of 272 pg/mL and a maximum of 1471 pg/mL.
15. The method of claim 8 , wherein the MSC are autologous.
16. The method of claim 8 , wherein the MSC are allogeneic.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 7, 2025
From: TOM, SAMSON; TON, CHRISTOPHER; DANILKOVITCH, ALLA
To: OSIRIS THERAPEUTICS, INC.
Reel/Frame 070446/0850 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 7, 2025
From: OSIRIS THERAPEUTICS, INC.
To: MESOBLAST INTERNATIONAL SÀRL
Reel/Frame 070446/0946 →
Continuity (8)
Provisional Application
61391452
· Oct 8, 2010
Provisional Application
61391482
· Oct 8, 2010
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