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

> **NIH NIH U01** · OSSIUM HEALTH, INC. · 2021 · $928,679

## Abstract

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.

## Key facts

- **NIH application ID:** 10168442
- **Project number:** 5U01AI138334-04
- **Recipient organization:** OSSIUM HEALTH, INC.
- **Principal Investigator:** ERIK J. WOODS
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $928,679
- **Award type:** 5
- **Project period:** 2018-04-19 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10168442

## Citation

> US National Institutes of Health, RePORTER application 10168442, OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome. (5U01AI138334-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10168442. Licensed CC0.

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