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OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome.

Award Number: U01AI138334
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/19/2018
PERIOD OF PERFORMANCE END DATE: 03/31/2023

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OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome. - ABSTRACT The hematopoietic subsyndrome of acute radiation syndrome (H-ARS) is induced with even moderate exposure to ionizing radiation, which is lethal to hematopoietic stem cells (HSC) in the bone marrow (BM). Hematopoietic stem cell transplant (HSCT) is a potential life-saving treatment for H-ARS victims; however, it is not generally recommended due to commonly associated complication of graft-versus-host disease. Recent clinical trials, including that of our collaborator, have demonstrated that mesenchymal stromal/stem cell (MSC) infusions prevent/treat graft-versus-host-disease (GVHD) and reduce graft failure following HSCT. These salutary effects of MSC are due to potent immunomodulatory properties of the cells. Furthermore, MSC possess many other therapeutic properties shown to ameliorate pathologies associated with other ARS syndromes effecting the gastrointestinal system, skin and liver. Thus, MSC have the potential to treat the full spectrum of pathologies associated with ionizing radiation exposure. Ossium Health is developing a unique source of BM-derived multipotent MSC obtained from deceased organ donors. This cellular therapy, termed OssioStem-M3 (matched multipotent MSC) has a distinct advantage over other MSC sources in that it is donor-matched to a source for HSCT grafts (OssioStem-HSC) obtained from the same donors. Additionally, the large volumes of BM that can be obtained from a deceased donor yield exceptionally high numbers of MSC. This is important given that efficacy of MSC for supporting HSCT is negatively related to passage number; thus, low passage OssioStem-M3 is superior to “third party” MSC obtained from living donors which must be amplified through many passages. We propose here to optimize methods for isolation of OssioStem-M3 and thoroughly characterize their physical characteristics and biological function. We also propose to demonstrate efficacy in large (porcine) and small (mouse) models of H-ARS. Finally, we will build and test next generation devices for increasing the consistency and throughput of OssioStem-HSC production. The overall product of this research program will be a robust production process and a compelling preclinical package to justify definitive studies to support FDA approval for H-ARS under the Animal Rule.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$140,369 )
2024	2022	OSSIUM HEALTH, INC.	78 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	5	3/25/2024	NON-COMPETING CONTINUATION	$0
2024	2022	OSSIUM HEALTH, INC.	78 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	5	4/8/2024	NON-COMPETING CONTINUATION	-$140,369
														Subtotal = -$140,369

Issue Date FY: 2022 ( Subtotal = $572,754 )
2022	2022	OSSIUM HEALTH, INC.	78 TEHAMA ST	SAN FRANCISCO	CA	94105	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	5	6/15/2022	NON-COMPETING CONTINUATION	$572,754
														Subtotal = $572,754

Issue Date FY: 2021 ( Subtotal = $997,220 )
2021	2021	OSSIUM HEALTH, INC.	1121 HOWARD ST	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	4	4/13/2021	NON-COMPETING CONTINUATION	$571,665
2021	2021	OSSIUM HEALTH, INC.	1121 HOWARD ST	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	002	4	8/26/2021	NON-COMPETING CONTINUATION	$357,014
2021	2021	OSSIUM HEALTH, INC.	1121 HOWARD ST	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	12/29/2020	SUPPLEMENT FOR EXPANSION	$68,541
														Subtotal = $997,220

Issue Date FY: 2020 ( Subtotal = $630,268 )
2020	2020	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	3	5/20/2020	NON-COMPETING CONTINUATION	$462,874
2020	2020	OSSIUM HEALTH, INC.	1121 HOWARD ST	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	003	3	8/20/2020	NON-COMPETING CONTINUATION	$32,089
2020	2019	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	002	2	5/21/2020	NON-COMPETING CONTINUATION	$87,984
2020	2018	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	5/20/2020	NEW	$47,321
														Subtotal = $630,268

Issue Date FY: 2019 ( Subtotal = $513,240 )
2019	2019	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	2	4/10/2019	NON-COMPETING CONTINUATION	$313,587
2019	2019	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	2	8/22/2019	NON-COMPETING CONTINUATION	$199,653
														Subtotal = $513,240

Issue Date FY: 2018 ( Subtotal = $276,039 )
2018	2018	OSSIUM HEALTH, INC.	25 TAYLOR ST	SAN FRANCISCO	CA	94102	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	4/19/2018	NEW	$276,039
														Subtotal = $276,039

Grand Total All Awards = $2,849,152

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OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome.

Award Number: U01AI138334

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/19/2018

PERIOD OF PERFORMANCE END DATE: 03/31/2023

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