# Design and production of an automated electronic tissue stem cell counter

> **NIH NIH R44** · ASYMMETREX, LLC · 2024 · $905,064

## Abstract

PROJECT SUMMARY
The applicant company, Asymmetrex® LLC, proposes a project to design and build the first laboratory
instrument that provides automated electronic counting of tissue stem cells (TSCs). Currently, no
instrument with this capability is available. Preparations containing TSCs like hematopoietic stem cells
(HSCs), which are used for approved stem cell transplantation therapies and experimental stem cell and
gene therapies, and mesenchymal stem cells (MSCs), which are the focus of many current stem cell
clinical trials, are administered without knowing the number of stem cells delivered. Quantitative TSC-
specific dosing would improve patients’ outcomes from approved stem cell treatments like HSC
transplantation and improve the design, statistical power, and interpretation of stem cell clinical trials.
There are similar needs for improving TSC research, cell and tissue biomanufacturing, and
pharmaceutical drug development that would be addressed by a convenient method to determine
the TSC-specific fraction (SCF) and dosage of treatment, research, production, and drug testing
samples, respectively. In the precursor SBIR Phase I project, Asymmetrex® successfully validated its
new kinetic stem cell (KSC) counting method with a head-to-head comparison to the only existing
method for quantifying the specific fraction of TSCs in a sample. That method, the SCID mouse
repopulating cell (SRC) assay, can be used to determine the specific fraction of only one type of TSCs,
HSCs. Even with its application for HSCs, the SRC assay has been of limited use for research and
medicine because its requirements are impractical for routine application. Using primary tissue cell
culture and computational simulation, Asymmetrex’s KSC counting method is the first-ever practical
solution for routine determination of the SCF of cell preparations from any tissue, including tissues from
human and animal donors. Being a computational method, KSC counting is ideal for implementation
with a small-footprint benchtop counting instrument. The currently available second iteration of the
KSC counting method requires only 72 hours of cell culture and conventional cell counting.
Asymmetrex® will design and build an instrument that automates the culture and counting of a tissue
cell preparation test sample and inputs the resulting data into on-board KSC counting algorithm
software that computes the SCF. The objective of this project is to design and build a manufacturing-
ready instrument that is validated for counting HSCs and MSCs found in common human tissue cell
sources used for research and medicine.

## Key facts

- **NIH application ID:** 10914530
- **Project number:** 2R44HL154900-02A1
- **Recipient organization:** ASYMMETREX, LLC
- **Principal Investigator:** JAMES L SHERLEY
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $905,064
- **Award type:** 2
- **Project period:** 2020-09-23 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10914530

## Citation

> US National Institutes of Health, RePORTER application 10914530, Design and production of an automated electronic tissue stem cell counter (2R44HL154900-02A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10914530. Licensed CC0.

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