# Mechanistic approach to optimization of a kidney preservation solution

> **NIH NIH R44** · TISSUE TESTING TECHNOLOGIES, LLC · 2022 · $385,522

## Abstract

The World Health Organization estimates that organ transplants are meeting less than 10% of global demand,
in part because the short preservation periods possible with current technology limits options for organ
assessment and sharing. Even potentially functional, transplantable organs may be turned down by one
transplant center after another until its short preservation limit is exceeded. We propose development of a new
stasis cocktail, based upon our Unisol™ solution, optimized for storage of kidneys that would enable cross
continent organ matching and exchange that in turn would potentially improve the lives of thousands of patients
with end stage renal disease. Our technology improves upon the most tried and true method for hypothermic
kidney storage in clinical practice that is relatively inexpensive, ice cooled, and easy to ship by air due to no need
for batteries or power supply. In this proposal we will assess optimization of Unisol™ for hypothermic kidney
storage by supplementation with compounds targeting specific mechanisms of ischemia and reperfusion injury
in five specific aims (SAs). In Phase I controls consisting of exposure to current clinical practice organ storage
solutions will be performed in both SAs. In SA#1 we sequentially test potential formulation supplements in vitro
on several human kidney cell types and then the best outcomes in an in vivo rat kidney transplant model. The in
vitro studies will be performed in our laboratories in South Carolina employing primary human renal epithelial
cells and the results will be confirmed using several types of primary human kidney cells. Cell viability assays
will be employed, including alamarBlue, live dead stains, Trypan blue, and the MTT assay, to identify the best
supplement formulations. In SA#2 in vivo studies to evaluate the best supplement formulations from SA#1 will
be performed at Johns Hopkins in Maryland using an orthotopic rat kidney transplant model under the direction
of Professor Gerald Brandacher. Successful demonstration of 100% animal/ kidney survival after 24h and >40%
after 36h of storage and 28 days post-transplant will be considered demonstration of feasibility for progression
to Phase II with 3 SAs. In Phase II we will scale up to porcine kidneys ex vivo (SA#3), followed by in vivo
transplantation (SA#4) and then ex vivo testing with human kidneys (SA#5). Tissue MALDI, proteomics and
proinflammatory cytokines will be also be assessed in SAs 2-5 to provide a better understanding of outcomes
and potentially suggest formulation modifications. We will transition from GMP to cGMP Unisol™ production for
Phase II. Larta, Inc., will assist Tissue Testing Technologies LLC in further development of our Phase II business
plans during Phase I and transitioning to the market place in Phase II.

## Key facts

- **NIH application ID:** 10545982
- **Project number:** 1R44DK133013-01A1
- **Recipient organization:** TISSUE TESTING TECHNOLOGIES, LLC
- **Principal Investigator:** Kelvin G.M. Brockbank
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $385,522
- **Award type:** 1
- **Project period:** 2022-08-19 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10545982

## Citation

> US National Institutes of Health, RePORTER application 10545982, Mechanistic approach to optimization of a kidney preservation solution (1R44DK133013-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10545982. Licensed CC0.

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