# Microfluidic Impedance Red Cell Assay (MIRCA) for Emerging Pharmacologic and Gene based Therapies for Sickle Cell Disease

> **NIH NIH R56** · CASE WESTERN RESERVE UNIVERSITY · 2022 · $663,187

## Abstract

PROJECT SUMMARY
 Acquired or inherited diseases can alter the red blood cell (RBC), causing severe clinical complications
affecting the vasculature and organ health. Inherited red cell disorders, renal failure, diabetes, and blood bank
storage lesions can all produce stiff, non-deformable RBCs. Red cell stiffness is particularly problematic in sickle
cell disease (SCD), a debilitating inherited blood disorder. An estimated 100,000 individuals in the US, and
millions more world-wide, have SCD. The field has experienced an explosion of novel SCD therapeutics,
designed to target specific individual abnormalities in the RBC in the last five years. Numerous gene-based
therapies intending to cure SCD are in clinical trials. This marked shift in SCD therapeutics produced a need for
diagnostics and analytical tools that assess RBC health and quality. We need biomarkers of red cell function to
serve as endpoints in clinical trials, assist in optimal drug selection and personalized monitoring for the individual,
and to determine if gene-based therapy has normalized the red cell. Many aspects of the red cell must be
assessed, but a key feature is deformability. There is a lack of robust, inexpensive devices sensitive enough to
capture small populations of poorly deformable red cells able to continue to hemolyze, damage the blood vessels,
and cause organ damage and early mortality. It is essential that we vet therapies for their ability to normalize the
entire population of red cells. Here we propose to develop and translate the Microfluidic Impedance Red Cell
Assay (MIRCA) to functionally measure red cell deformability, reported as Occlusion Index (OI) of a biomimetic
microcapillary network array on a chip. We propose an innovative approach and a novel collaboration between
engineers and a hematology-trained physician scientist. We will do so with the following steps:
1. We will achieve instrumentation and analytical validation of MIRCA measurement of red cell OI. Analytic
 validation will be performed both in PI’s laboratory (Dr. Umut Gurkan, CWRU) and in Co-I’s hematology
 laboratory (Dr. Vivien Sheehan, Emory) to prove generalizability and permit stakeholder feedback and design
modification.
2. We will clinically validate MIRCA by assessing the association between OI and clinical complications and
 traditional laboratory measures of disease severity in SCD.
3. We will expand the use of the optimized MIRCA to the clinical space by demonstrating its prognostic value
 in longitudinal assessments of patients with SCD experiencing clinical complications and transitions in
therapy.
 Using our unique collaboration between biomedical engineers and a hematology trained physician-scientist,
we will optimize, validate, and achieve clinical adoption of MIRCA technology in clinical trials and patient care
for individuals living with SCD in the US and world-wide.

## Key facts

- **NIH application ID:** 10687427
- **Project number:** 1R56HL165946-01
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Umut A. Gurkan
- **Activity code:** R56 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $663,187
- **Award type:** 1
- **Project period:** 2022-09-12 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10687427

## Citation

> US National Institutes of Health, RePORTER application 10687427, Microfluidic Impedance Red Cell Assay (MIRCA) for Emerging Pharmacologic and Gene based Therapies for Sickle Cell Disease (1R56HL165946-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10687427. Licensed CC0.

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