# Rapid, single-step precision engineering and pre-clinical evaluation of chimeric antigen receptor Regulatory T cells for Type 1 diabetes

> **NIH NIH R43** · INDEE, INC · 2022 · $309,636

## Abstract

Ex vivo engineering of patient-derived regulatory T (Treg) cells holds promise as a safe and effective approach
for treating type 1 diabetes (T1D). Despite promising preclinical studies, considerable biological and technical
hurdles must be addressed before this therapeutic strategy can be realized. First, Treg cells must be engineered
to optimally enhance their specificity, stability, and functionality. Second, scalability issues – or generating
sufficient yield of patient-derived, ex vivo engineered cells to constitute a therapeutic dose – must be overcome.
Indee. Inc. is addressing all of these challenges with their Hydropore™ platform. Hydropore™ uses a naturally
occurring fluid dynamics phenomenon – vortex shedding – to enable Treg cell engineering that enhances the
stability, functionality, and scalability issues in less time than the current gold standards that use virus-based
methods and electroporation. HydroporeTM ultimately results in more effective engineered T cells such as Tregs.
In this proposal, Indee. Inc. will demonstrate the technical performance of Hydropore™ in engineering the next
generation of chimeric antigen receptor regulatory T cells (CAR-Tregs) for T1D. Studies will also focus on
demonstrating the superior in vitro and in vivo biological activity of CAR-Tregs engineered using HydroporeTM
relative to those engineered using traditional methods. Pending the successful completion of these objectives,
CAR-Tregs will be engineered using Treg cells isolated from T1D patients and demonstrate clinical- and
commercial-scale processing and enrichment of sufficient CAR-Tregs cells for human trials.

## Key facts

- **NIH application ID:** 10477106
- **Project number:** 1R43DK133029-01
- **Recipient organization:** INDEE, INC
- **Principal Investigator:** Ryan Pawell
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $309,636
- **Award type:** 1
- **Project period:** 2022-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10477106

## Citation

> US National Institutes of Health, RePORTER application 10477106, Rapid, single-step precision engineering and pre-clinical evaluation of chimeric antigen receptor Regulatory T cells for Type 1 diabetes (1R43DK133029-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10477106. Licensed CC0.

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