Purified mesenchymal stem cell compositions and methods of purifying mesenchymal stem cell compositions

• US 8,637,004 B2
• Filed: 08/14/2009
• Issued: 01/28/2014
• Est. Priority Date: 08/14/2008
• Status: Active Grant

• Current Assignee: Mesoblast International Srl
• Original Assignee: Mesoblast International SARL (Mesoblast Ltd.)
• Inventors: Danilkovich, Alla, Tom, Samson, Ton, Christopher, Wang, Zhanling, Young, Randell G., Newman, Robert E. Jr.
• Primary Examiner(s): Driscoll, L B
• Application Number:
  US12/541,282
• Publication Number:
  US 20100068191A1
• Time in Patent Office: 1,628 Days
• Field of Search: None
• US Class Current: 424/93.7
• CPC Class Codes: A61K 2035/124 the cells being hematopoietic, bone marrow derived or blood cells
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12N 5/0663 Bone marrow mesenchymal stem cells (BM-MSC)

Abstract

One or more purified mesenchymal stem cell pharmaceutical compositions and methods of manufacture utilizing centrifugal filtration are disclosed. Threshold limits for intravenous administration of mesenchymal stem cell pharmaceutical compositions comprising residual animal products are also disclosed.

Claims

1. A pharmaceutically acceptable composition comprising purified mesenchymal stem cells, wherein the composition comprises one or more mesenchymal stem cell aggregates and wherein the diameter which is greater than 90% or more of said aggregates (D₉₀) is less than about 150 μ

m.

2. The pharmaceutically acceptable composition of claim 1, wherein the D₉₀ of said aggregates is less than about 100 μ

m.

3. The pharmaceutically acceptable composition of claim 2, wherein the D₉₀ of said aggregates is less than about 50 μ

m.

4. The pharmaceutically acceptable composition of claim 1, wherein the portion of the purified mesenchymal stem cells which are viable is greater than about 70%.

5. The pharmaceutically acceptable composition of claim 4, wherein the portion of the purified mesenchymal stem cells which are viable is greater than about 80%.

6. A pharmaceutically acceptable composition comprising purified mesenchymal stem cells, wherein the composition comprises less than about 55 μ

g/mL bovine serum albumin and wherein the composition comprises one or more mesenchymal stem cell aggregates and wherein the diameter which is greater than 90% of said aggregates (D₉₀) is between about 18 μ

m and about 30 μ

m.

7. The composition of claim 6, wherein the composition comprises less than about 42 μ

g/mL bovine serum albumin.

8. The composition of claim 7, wherein the composition comprises less than about 25 μ

g/mL bovine serum albumin.

9. The composition of claim 8, wherein the composition comprises less than about 13 μ

g/mL bovine serum albumin.

10. The composition of claim 9, wherein the composition comprises less than about 10 μ

g/mL bovine serum albumin.

11. The composition of claim 6, wherein the composition comprises between about 7 μ

g/mL and about 15 μ

g/mL bovine serum albumin.

12. The composition of claim 11, wherein the composition comprises between about 8 μ

g/mL and about 12 μ

g/mL bovine serum albumin.

13. The composition of claim 6, wherein the D₉₀ is between about 18 μ

m and about 25 μ

m.

14. The composition of claim 6, wherein the portion of the purified mesenchymal stem cells which are viable is greater than about 70%.

15. The composition of claim 14, wherein the portion of the purified mesenchymal stem cells which are viable is greater than about 80%.