# Regenerative Therapy for Corneal Endothelial Dystrophies and Injuries

> **NIH NIH R42** · RASHMIVU, LLC · 2020 · $300,000

## Abstract

Summary
Worldwide, only 1 out of 70 patients with corneal endothelial dystrophies and injuries receive a corneal
transplant due to the limited corneal donor pool, the need for advanced surgical facilities and talent, and
expense. RashmiVu is developing a stem cell based regenerative technology that addresses this large unmet
global need through a paradigm shift, wherein treatment could be as simple as an intracameral injection of
stem cells as an outpatient procedure. RashmiVu has repeatedly demonstrated successful isolation and
expansion of human corneal endothelial stem cells (hCESCs) into millions, confirmed that these cells are
hCESCs by analysis of phenotypic markers, and demonstrated their regenerative potential in preliminary
animal studies in both mice and rabbits. This Fast-Track STTR seeks to complete development and
demonstrate potential products including (a) a single cell suspension for intracameral injection, (b) a single cell
formulation that can be “painted” onto the corneal endothelium, and (c & d) sheets of hCESCs and/or their
differentiated mature corneal endothelial phenotypes for use in DSEK and DMEK surgeries.
Phase I Specific Aims: 1. Cell Yield: Determine tissue procurement inclusion/exclusion criteria that reliably
yield 5M+ hCESCs/donor eye, and optimize differentiation to maximize yield of mature CEC phenotypes; 2.
Definitive healing: Rapid innate healing in rabbits obfuscates effects of hCESCs (see Prelim Data). The team
will complete development of a slow-healing cryoinjury rabbit model and demonstrate definitive hCESC
efficacy; 3. Mechanisms: Determine mechanisms potentiated by or convertible to a pharmaceutical pathway.
Phase II Specific Aims: 4. Cell suspension formulations: Optimize cell suspensions for injection and targeted
delivery including ROCKi pre-treatment, and optimize media and methods for high cell survival after freezing,
storage, thawing, and revival; 5. Cell Sheets: Develop monolayer sheets of hCESCs on transplantable
substrates, develop a method for consistent differentiation of the hCESC monolayer into a mature CEC
monolayer on these sheets, and demonstrate successful partial thickness transplantation (DSEK) in rabbits; 6.
Dosage, Safety & Efficacy: Initiate FDA-recommended pre-clinical trials to demonstrate safety, efficacy,
effectiveness of targeted delivery approaches including dose response, cell survival, engraftment, distribution,
migration, proliferation, tumorigenicity, host immune response, and cellular toxicities.
A successful regenerative treatment for corneal endothelial dystrophies and damages could dramatically
reduce health care costs, eliminate blindness, and return people to fully functioning members of society, all
with an attractive market opportunity.

## Key facts

- **NIH application ID:** 9910087
- **Project number:** 1R42EY031196-01
- **Recipient organization:** RASHMIVU, LLC
- **Principal Investigator:** HIRANMOY DAS
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910087

## Citation

> US National Institutes of Health, RePORTER application 9910087, Regenerative Therapy for Corneal Endothelial Dystrophies and Injuries (1R42EY031196-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9910087. Licensed CC0.

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