# Automated System for High Yield Pancreatic Islet Isolation

> **NIH NIH R44** · CG SCIENTIFIC, INC. · 2021 · $749,988

## Abstract

Project Summary/Abstract
This Phase II project aims to develop an automated system for high-yield pancreatic islet isolation for
use in islet transplantation (an emerging therapy for type 1 diabetes) and diabetes research. The
effectiveness of islet transplantation relies critically on the quality and quantity of the transplanted islets,
which are isolated from deceased human donor pancreata. However, the current method for islet
isolation is highly user-dependent, provides low numbers of islets, and suffers close to 50% process
failure rates. These drawbacks necessitate the frequent use of many donor pancreata and multiple
transplants per patient to achieve good outcomes, making islet transplantation highly inefficient and cost-
prohibitive. The lack of a reliable and easy-to-use tool for islet isolation also precludes many researchers
from obtaining high-quality islets for their research. To overcome these limitations, CG Scientific is
developing a patent-pending “automated cell isolation platform” (ACIP) technology to create an
automated system for islet isolation. The technology has a unique configuration to (1) enable efficient
enzyme digestion, (2) automate the isolation process in a closed-system format, and (3) break through
limitations that prevent current methods from achieving high islet recovery and viability. Using porcine
pancreata as a model system in Phase I, the company has demonstrated successful islet isolation, with
~2.4x higher islet recovery compared to the current method and an unmatched islet viability of ~95% on
average. The islets exhibit outstanding morphology and glucose-stimulated insulin secretion function.
The automated system will potentially eliminate user-related process failure and render single-donor islet
transplantation highly efficacious―using only one donor pancreas and one transplant per recipient―with
up to 80% cost reduction. In Phase II, the investigator team will (1) develop a fully functional product
prototype, (2) optimize the performance of the automated prototype for both human and porcine islets,
(3) benchmark superior islet isolation capabilities compared to the current method, and (4) demonstrate
the pre-clinical efficacy of the resulting islets for diabetes reversal using a mouse model. This Phase II
project will generate significant data and know-how for (1) transitioning to manufacturing, (2) obtaining
regulatory approval, and (3) product commercialization. The investigator team includes medical device
experts, islet biologists, engineers, and medical doctors who specialize in clinical islet manufacturing and
transplantation. The success of this project will result in the commercialization of an essential tool that
will not only make single-donor islet transplantation highly effective, affordable, and available, but also
accelerate a wide range of diabetes research―thereby benefiting the many patients around the world
who suffer from diabetes.

## Key facts

- **NIH application ID:** 10258555
- **Project number:** 2R44DK112468-02
- **Recipient organization:** CG SCIENTIFIC, INC.
- **Principal Investigator:** Lotien Richard Huang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $749,988
- **Award type:** 2
- **Project period:** 2017-09-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258555

## Citation

> US National Institutes of Health, RePORTER application 10258555, Automated System for High Yield Pancreatic Islet Isolation (2R44DK112468-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10258555. Licensed CC0.

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