IP Library › Granted Patent US 11,162,078
Granted Patent B2
US 11,162,078 · App. 16/934,412 · Granted Nov 2, 2021

SC-beta cells and compositions and methods for generating the same

Inventors: Quinn P. Peterson (Rochester, MN); Felicia J. Pagliuca (Boston, MA); Douglas A. Melton (Lexington, MA); Jeffrey R. Millman (St. Louis, MO); Michael Saris Segel (Brookline, MA); Mads Gurtler (Kongens Lyngby, DK)
Assignee: President and Fellows of Harvard College
C12N5/0678C12N5/0606C12N5/0676C12N5/0696C12N2501/11C12N2501/117C12N2501/15C12N2501/16C12N2501/375C12N2501/385C12N2501/395C12N2501/40C12N2501/41C12N2501/727C12N2501/998C12N2501/999C12N2506/02C12N2506/03C12N2506/22C12N2506/45
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Quick Facts
Patent No.
US 11,162,078
App. No.
16/934,412
Granted
Nov 2, 2021
Kind
B2
Abstract

Disclosed herein are methods, compositions, kits, and agents useful for inducing β cell maturation, and isolated populations of SC-β cells for use in various applications, such as cell therapy.

Claims (29)

1. An in vitro composition that comprises:

a) betacellulin and one or more of a retinoic acid signaling pathway activator, a sonic hedgehog pathway inhibitor, and a TGF-beta pathway inhibitor; and

b) a plurality of pancreatic progenitor cells that express PDX1 and NKX6.1.

2. The composition of claim 1 , wherein the composition comprises two or more of the retinoic acid signaling pathway activator, the sonic hedgehog pathway inhibitor, and the TGF-beta pathway inhibitor.

3. The composition of claim 2 , wherein the composition comprises the retinoic acid signaling pathway activator, the sonic hedgehog pathway inhibitor, and the TGF-beta pathway inhibitor.

4. The composition of claim 1 , wherein the composition comprises a retinoic acid signaling pathway activator, wherein the retinoic acid signaling pathway activator is selected from the group consisting of: retinoic acid, CD 1530, AM 580, TTNPB, CD 437, Ch 55, BMS 961, AC 261066, AC 55649, AM 80, BMS 753, tazarotene, adapalene, CD 2314, DEAB, BMS 195614, ER 50891, BMS 493, CD 2665, LE 135, BMS 453, and MM 11253.

5. The composition of claim 4 , wherein the retinoic acid signaling pathway activator is retinoic acid.

6. The composition of claim 1 , wherein the composition comprises a sonic hedgehog inhibitor, and wherein the sonic hedgehog pathway inhibitor is selected from the group consisting of: Sant1, Sant2, Sant3, Sant4, Cur61414, forskolin, tomatidine, AY9944, and triparanol.

7. The composition of claim 6 , wherein the sonic hedgehog pathway inhibitor is Sant1.

8. The composition of claim 1 , wherein the composition comprises a TGF-beta pathway inhibitor, wherein the TGF-beta pathway inhibitor is selected from the group consisting of: ALK5 inhibitor II, A83-01, SB 431542, D 4476, GW 788388, LY 364947, LY 580276, SB 525334, SB 505124, SD 208, and GW 6604.

9. The composition of claim 8 , wherein the TGF-beta pathway inhibitor is ALK5 inhibitor II.

10. The composition of claim 1 , wherein the betacellulin has a concentration of 2 ng/mL-200 ng/mL.

11. The composition of claim 3 , wherein:

a) the retinoic acid signaling pathway activator is selected from the group consisting of: retinoic acid, CD 1530, AM 580, TTNPB, CD 437, Ch 55, BMS 961, AC 261066, AC 55649, AM 80, BMS 753, tazarotene, adapalene, CD 2314, DEAB, BMS 195614, ER 50891, BMS 493, CD 2665, LE 135, BMS 453, and MM 11253,

b) the sonic hedgehog pathway inhibitor is selected from the group consisting of: Sant1, Sant2, Sant3, Sant4, Cur61414, forskolin, tomatidine, AY9944, and triparanol, and

c) the TGF-beta pathway inhibitor is selected from the group consisting of: ALK5 inhibitor II, A83-01, SB 431542, D 4476, GW 788388, LY 364947, LY 580276, SB 525334, SB 505124, SD 208, and GW 6604.

12. The composition of claim 3 , wherein the retinoic acid signaling pathway activator comprises retinoic acid, the sonic hedgehog pathway inhibitor comprises SANT1, and the TGF-beta pathway inhibitor comprises Alk5 inhibitor II.

13. The composition of claim 3 , wherein the composition further comprises insulin-expressing cells.

14. A method of in vitro cell differentiation, comprising:

contacting an in vitro cell population comprising pancreatic progenitor cells that express PDX1 and NKX6.1 with a retinoic acid signaling pathway activator, a sonic hedgehog pathway inhibitor, a TGF-beta pathway inhibitor, and betacellulin; wherein the method results in a plurality of the pancreatic progenitor cells in the population to differentiate into insulin-expressing cells.

15. The method of claim 14 , wherein the cell population is contacted with the betacellulin for 1 or 2 days.

16. The method of claim 14 , wherein the insulin-expressing cells express NKX6.1 and Chromogranin A.

17. The method of claim 14 , wherein the retinoic acid signaling pathway activator comprises retinoic acid, the sonic hedgehog pathway inhibitor comprises SANT1, and the TGF-beta pathway inhibitor comprises Alk5 inhibitor II.

18. The method claim 14 , wherein the pancreatic progenitor cells that express PDX1 and NKX6.1 are generated from stem cells in vitro.

19. The method of claim 14 , wherein:

a) the retinoic acid signaling pathway activator is selected from the group consisting of: retinoic acid, CD 1530, AM 580, TTNPB, CD 437, Ch 55, BMS 961, AC 261066, AC 55649, AM 80, BMS 753, tazarotene, adapalene, CD 2314, DEAB, BMS 195614, ER 50891, BMS 493, CD 2665, LE 135, BMS 453, and MM 11253,

b) the sonic hedgehog pathway inhibitor is selected from the group consisting of: Sant1, Sant2, Sant3, Sant4, Cur61414, forskolin, tomatidine, AY9944, and triparanol, and

c) the TGF-beta pathway inhibitor is selected from the group consisting of: ALK5 inhibitor II, A83-01, SB 431542, D 4476, GW 788388, LY 364947, LY 580276, SB 525334, SB 505124, SD 208, and GW 6604.

20. The method claim 1 , wherein the pancreatic progenitor cells that express PDX1 and NKX6.1 are generated from stem cells in vitro.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 20, 2021
From: MELTON, DOUGLAS A.
To: HOWARD HUGHES MEDICAL INSTITUTE
Reel/Frame 057525/0158 →
APPOINTMENT OF AGENT Recorded Sep 20, 2021
From: HOWARD HUGHES MEDICAL INSTITUTE
To: MELTON, DOUGLAS A.
Reel/Frame 057539/0855 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 20, 2021
From: PETERSON, QUINN P.; PAGLIUCA, FELICIA J.; MELTON, DOUGLAS A.; MILLMAN, JEFFREY R.; SEGEL, MICHAEL SARIS; GURTLER, MADS; HOWARD HUGHES MEDICAL INSTITUTE
To: PRESIDENT AND FELLOWS OF HARVARD COLLEGE
Reel/Frame 057539/0871 →
Continuity (5)
Continuation 14684129 · Apr 10, 2015
Continuation PCTUS2014041992 · Jun 11, 2014
Provisional Application 61972212 · Mar 28, 2014
Provisional Application 61833898 · Jun 11, 2013
Related Publication 20200385681A1 · Dec 10, 2020