US 12,303,532 B2
Combined organ and hematopoietic cells for transplantation tolerance of grafts
Samuel Strober, Stanford, CA (US); and Robert Lowsky, Stanford, CA (US)
Assigned to The Board of Trustees of the Leland Stanford Junior University, Stanford, CA (US)
Filed by The Board of Trustees of the Leland Stanford Junior University, Stanford, CA (US)
Filed on Jul. 25, 2022, as Appl. No. 17/872,741.
Application 17/872,741 is a continuation of application No. 16/447,691, filed on Jun. 20, 2019, granted, now 11,426,429.
Application 16/447,691 is a continuation of application No. 16/291,492, filed on Mar. 4, 2019, granted, now 11,116,794, issued on Sep. 14, 2021.
Application 16/291,492 is a continuation of application No. 16/100,828, filed on Aug. 10, 2018, granted, now 10,258,648, issued on Apr. 16, 2019.
Application 16/100,828 is a continuation of application No. 15/914,746, filed on Mar. 7, 2018, granted, now 10,076,542, issued on Sep. 18, 2018.
Application 15/914,746 is a continuation of application No. 15/387,292, filed on Dec. 21, 2016, granted, now 9,974,807, issued on May 22, 2018.
Application 15/387,292 is a continuation of application No. 14/438,159, granted, now 9,561,253, issued on Feb. 7, 2017, previously published as PCT/US2014/015394, filed on Feb. 7, 2014.
Claims priority of provisional application 61/769,596, filed on Feb. 26, 2013.
Prior Publication US 2022/0362291 A1, Nov. 17, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/17 (2025.01); A61K 31/365 (2006.01); A61K 31/436 (2006.01); A61K 31/573 (2006.01); A61K 35/12 (2015.01); A61K 35/14 (2015.01); A61K 35/22 (2015.01); A61K 35/28 (2015.01); A61K 38/13 (2006.01); A61K 38/19 (2006.01); A61K 39/00 (2006.01); A61K 39/395 (2006.01); A61K 40/10 (2025.01); A61K 40/11 (2025.01); A61K 40/22 (2025.01); A61K 40/41 (2025.01); A61K 41/00 (2020.01); A61K 45/06 (2006.01); A61N 5/10 (2006.01); C12N 5/078 (2010.01); C12N 5/0783 (2010.01)
CPC A61K 35/12 (2013.01) [A61K 31/365 (2013.01); A61K 31/436 (2013.01); A61K 31/573 (2013.01); A61K 35/14 (2013.01); A61K 35/22 (2013.01); A61K 35/28 (2013.01); A61K 38/13 (2013.01); A61K 38/193 (2013.01); A61K 39/001 (2013.01); A61K 39/39541 (2013.01); A61K 40/10 (2025.01); A61K 40/11 (2025.01); A61K 40/22 (2025.01); A61K 40/418 (2025.01); A61K 41/00 (2013.01); A61K 45/06 (2013.01); A61N 5/10 (2013.01); C12N 5/0634 (2013.01); C12N 5/0636 (2013.01); A61K 2035/122 (2013.01); A61K 2035/124 (2013.01); A61K 39/395 (2013.01); A61K 2039/515 (2013.01); A61K 2039/54 (2013.01); A61K 2039/57 (2013.01); A61K 2239/31 (2023.05); A61K 2239/38 (2023.05)] 19 Claims
 
1. A method for manufacturing a cellular product, the method comprising:
receiving an apheresis product from a donor comprising CD34+ cells and CD3+ cells;
processing the apheresis product to produce a cellular product comprising an effective amount of CD34+ cells/kilogram recipient weight in a cryopreservation solution; an effective amount of at least 1×107 CD3+ T cells/kilogram recipient weight in the cryopreservation solution; and a cell type in the cryopreservation solution that facilitates engraftment of the hematopoietic stem cells in a bone marrow of a recipient of a solid organ transplant; and
analyzing the cellular product for one or more quality criteria.