US 11,697,799 B2
System and method for extraction and cryopreservation of bone marrow
Erik John Woods, Carmel, IN (US); Brian H. Johnstone, Fishers, IN (US); Dongsheng Gu, Indianapolis, IN (US); Aubrey Marie Sherry, Carmel, IN (US); Kelsey Gwen Musall, Avon, IN (US); John R. Woods, Indianapolis, IN (US); James Hardin, Columbia, SC (US); and Alan Hooks, Commerce City, CO (US)
Assigned to Ossium Health, Inc., San Francisco, CA (US)
Filed by Ossium Health, Inc., San Francisco, CA (US)
Filed on Jan. 6, 2020, as Appl. No. 16/734,713.
Claims priority of provisional application 62/938,480, filed on Nov. 21, 2019.
Claims priority of provisional application 62/834,087, filed on Apr. 15, 2019.
Prior Publication US 2020/0325451 A1, Oct. 15, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. C12N 5/0775 (2010.01); A61B 17/16 (2006.01); A01N 1/02 (2006.01); A61B 17/00 (2006.01)
CPC C12N 5/0663 (2013.01) [A01N 1/0221 (2013.01); A61B 17/1611 (2013.01); A61B 2017/00831 (2013.01)] 19 Claims
 
1. A method for manipulating environmental conditions of a cadaver such that stem cells obtained from bone explanted from the cadaver comprise CD34+ cells, among which at least 70% of the recovered CD34+ cells are viable, the method comprising steps of:
(1) identifying a human who is nearing death;
(2) recording the time of death of the human, at this time the human becomes a cadaver;
(3) placing the cadaver or an explanted bone from the cadaver into a cooling environment;
(4) recording the time when step (3) occurs;
wherein the period of time from step (2) to step (3) is referred to as the warm ischemia time (WIT) and step (3) is performed from no less than about one-half to no more than about eight hours after step (2);
(5) processing the cadaver bone for extraction of stem cells; and
(6) recording the time when step (5) begins;
wherein the period of time from step (3) to step (5) is referred to as the cold ischemia time (CIT) and step (5) is performed from no less than about seven hours to no more than about thirty-nine and one-half hours after step (3);
wherein WIT and CIT are distinct periods of time;
wherein the sum of WIT and CIT is forty hours or less such that
when the WIT is more than one-half hour, the CIT is no more than thirty-nine and one-half hours and
when the WIT is about eight hours, the CIT is no more than thirty-two hours; and
wherein the stem cells comprise CD34+ cells, among which at least 70% of the recovered CD34+ cells are viable
wherein when the sum of WIT and CIT is greater than forty hours and/or WIT is greater than eight hours and/or CIT is greater than about thirty-nine and one-half hours, fewer recovered CD34+ cells will be viable when compared to when the sum of WIT and CIT is forty hours or less and/or WIT is from no less than about one-half to no more than about eight hours and/or CIT is from no less than about seven hours to no more than about thirty-nine and one-half hours.