# MPS Resources Section

> **NIH NIH U2C** · UNIVERSITY OF WASHINGTON · 2024 · $610,076

## Abstract

ABSTRACT - MPS Resources Section
Predicting the safety and efficacy of candidate therapeutics, including their mechanisms of action and likelihood
of success in patients, requires fundamentally new strategies, assays, and models of the kidney that better
replicate human pathophysiology. Recently, human cellular models in vitro have emerged that can recapitulate
critical aspects of kidney physiology, mimic the unique complexities of specific nephron segments, model disease
heterogeneity, and assess injury-repair mechanisms, with great potential to accelerate and enable therapy
development. Induced pluripotent stem (iPS) cells are a powerful source for such models, as they are self-
renewing (immortal), can change into diverse cell types, and are amenable to gene editing.
Human models endogenously express species-specific target genes and have unique advantages for
mechanistic analysis and throughput. The FDA Modernization Act 2.0 “allows an applicant for market approval
for a new drug to use methods other than animal testing to establish the drug's safety and effectiveness.”
However, the complexity and limited availability of human microphysiological models, their lack of
standardization, and questions regarding their appropriateness and clinically-relevant interpretation, need to be
addressed in order for these to be brought into widespread use. Qualification of these systems as drug
development tools will be helpful for achieving this and enabling use to provide clinical guidance.
To bridge this gap, the overarching goal of the Kidney MPS Resources Section is, in collaboration with
commercial partners to manufacture and share qualification-grade kidney-on-chip platforms for two innovative
human cellular models: the proximal tubule kidney chip microphysiological system (PTEC-MPS), and the human
kidney organoid-on-chip. These two systems are complementary, enabling (respectively) apical and basolateral
tubular perfusion and heterocellular modeling of genetic disease. Each model will be improved to produce more
biomimetic qualities. We will further cross-translate these two cellular models by constructing PTEC-MPS using
organoid-derived tubular epithelial cells for the first time.
We will achieve these goals with two complementary Specific Aims: (1) Establish reference standard kidney
MPS by detailing operating procedures, quality controls, validation datasets, and longevity characteristics. (2)
Iteratively optimize kidney MPS to incorporate features relevant for qualification. These Aims will establish
rigorous kidney chips appropriate for qualification by regulatory agencies and advance their transfer from
academic laboratories to commercial industry. Each Aim will be accompanied by specific Milestones that track
the major steps necessary to accomplish this bench-to-business effort.

## Key facts

- **NIH application ID:** 10816295
- **Project number:** 1U2CTR004867-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Benjamin Solomon Freedman
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $610,076
- **Award type:** 1
- **Project period:** 2024-02-01 → 2024-09-22

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10816295

## Citation

> US National Institutes of Health, RePORTER application 10816295, MPS Resources Section (1U2CTR004867-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10816295. Licensed CC0.

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