# Enhancing Rigor and Reproducibility of Translational Nonhuman Primate Models for Genetic and Regenerative Therapies

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2024 · $781,525

## Abstract

This application is submitted in response to PAR-23-040 with the goal of integrating cutting-edge in vivo
imaging technologies and key immunologic assessments to enhance the rigor and reproducibility of
translational nonhuman primate models for genetic and regenerative therapies. The proposal meets the
objective of PAR-23-040, which is focused on “…developing and implementing broadly applicable
technologies, tools, and resources for...enhancing rigor, reproducibility, and translatability of animal research”.
We will support translational research by incorporating total-body positron emission tomography (PET) and
correlative assessments of the immune system. The investigations proposed will enhance the rhesus monkey
model system by creating or improving study protocols that provide a high level of sensitivity and reproducibility
for assessments that are important to clinical translation. The Specific Aims are: (1) Use total-body PET
imaging to longitudinally monitor gene transfer and biodistribution in preclinical studies of fetal or juvenile
rhesus monkeys for clinical translation, and (2) Explore new readouts of immune responses to innovative
therapeutics in tissue sites using T-cell tracking in translational nonhuman primate studies. These
investigations will address relationships between local T-cell infiltration and circulating immunophenotypes with
correlative in vivo imaging, which will enhance models and provide new methods to assess the primate
immune system. Monitoring inflammation and immunity in targeted and non-targeted tissues is critically
important to ensure safety as new therapeutics transition to the clinic for a range of common and rare
diseases. These studies will provide predictive protocols and tools which will inform preclinical and IND-
enabling studies for future human applications across age groups.

## Key facts

- **NIH application ID:** 10858290
- **Project number:** 1R01OD036239-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** DENNIS J. HARTIGAN-O'CONNOR
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $781,525
- **Award type:** 1
- **Project period:** 2024-07-01 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10858290

## Citation

> US National Institutes of Health, RePORTER application 10858290, Enhancing Rigor and Reproducibility of Translational Nonhuman Primate Models for Genetic and Regenerative Therapies (1R01OD036239-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10858290. Licensed CC0.

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