# Optimizing Industrial-Scale GMP Processes for Recovering and Banking Deceased Donor Bone Marrow

> **NIH NIH R44** · OSSIUM HEALTH, INC. · 2020 · $999,998

## Abstract

ABSTRACT
This program aims to optimize a method for banking clinical-grade bone marrow from organ
donors that can be deployed nationally to ameliorate shortages, provide bone marrow stockpiles
as medical countermeasures for nuclear threats, and support existing research approaches such
as delayed immune tolerance induction and transfusion of HIV-resistant stem cells.
In Phase I we adapted protocols developed by our research team for procurement, processing,
and banking bone marrow from cadaveric vertebral bodies and ilia, which were shown to produce
high yields of viable hematopoietic stem cells and other bone marrow cells from donors after
varying lengths of warm and cold ischemic times. Equations have been derived from these data
which have allowed modeling the effects of warm and cold ischemia on hematopoietic stem cell
viability and function. These predictive models provide the tools necessary for completing
optimization of the recovery and isolation protocols. In this proposal we will make key refinements
to our method for deployment on a large scale, which will allow recovery at geographically diverse
organ procurement agencies and shipment to a centralized facility for processing. The end result
will be a large supply of bone marrow that can be used on-demand, off the shelf, complementing
existing bone marrow donor registries and cord blood banks.
The technical objectives of this Phase 2 study are to (1) optimize preservation of stem cells in
whole vertebrae shipped to Ossium’s central processing facility, (2) maximize recovery of viable
stem cells exposed to long warm ischemia times, and (3) validate the final optimized process. In
Aim 1, we will optimize preservation solutions for procurement and shipment of donor vertebral
body bone marrow. In Aim 2, we will optimize whole bone marrow isolation solutions to maximize
recovery of viable cells. In Aim 3, we will validate all processes by building and testing a pilot bank
and comparing deceased donor and aspirated bone marrow in a mouse xenotransplantation
study. The outcome of these aims will determine the most effective system for procurement,
processing and banking of cadaveric bone marrow for clinical use on a large scale.

## Key facts

- **NIH application ID:** 9926831
- **Project number:** 5R44AI129444-03
- **Recipient organization:** OSSIUM HEALTH, INC.
- **Principal Investigator:** ERIK J. WOODS
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $999,998
- **Award type:** 5
- **Project period:** 2017-02-03 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9926831

## Citation

> US National Institutes of Health, RePORTER application 9926831, Optimizing Industrial-Scale GMP Processes for Recovering and Banking Deceased Donor Bone Marrow (5R44AI129444-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9926831. Licensed CC0.

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