# 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 · $68,541

## Abstract

Abstract of funded parent award
 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.
Abstract for supplement
 Supplemental funds are requested to cover a budget deficit caused by having to place the
porcine H-ARS study at a new study site after the original site (Altasciences) discontinued their
program. These funds will be used to cover the porcine H-ARS study budgetary shortfall and
add a control arm. The supplemental amount requested is based on a quote provided by CRL
on September 11, 2020 (quote number CRL272922). The amount quoted for 4 study groups
was $389,580. With the inclusion of the additional of optional histopathology costs ($39,800),
the total cost for the study was brought to $429,380 (ie., the sum of $389,580 + $39,800). Not...

## Key facts

- **NIH application ID:** 10271661
- **Project number:** 3U01AI138334-03S1
- **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:** $68,541
- **Award type:** 3
- **Project period:** 2018-04-19 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10271661

## Citation

> US National Institutes of Health, RePORTER application 10271661, OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome. (3U01AI138334-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10271661. Licensed CC0.

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