Development of a new kit for preserving corneas for transplantation
Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback
['FUNDING_SBIR_2'] · CRYOCRATE, LLC · NIH-10476603
This study is testing a new kit called IcyEye® that helps keep donated corneas safe and healthy while they are frozen, so they can be stored for a long time and used effectively, especially during emergencies like pandemics.
Quick facts
| Phase | ['FUNDING_SBIR_2'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | CRYOCRATE, LLC (nih funded) |
| Locations | 1 site (COLUMBIA, UNITED STATES) |
| Trial ID | NIH-10476603 on ClinicalTrials.gov |
What this research studies
This research focuses on creating a novel corneal cryopreservation kit called IcyEye®, which includes a specialized medium and a mechanical device designed to protect corneal tissues during freezing. The kit allows for long-term storage of corneas at -80°C while maintaining high cell viability and tissue quality after thawing. By improving the preservation of corneas, this technology aims to enhance the efficiency of eye banks and ensure they can operate effectively during health crises, such as pandemics. The project is guided by feedback from the FDA to ensure compliance and safety for clinical use.
Who could benefit from this research
Good fit: Ideal candidates for this research are individuals requiring corneal transplants due to conditions like corneal blindness or damage.
Not a fit: Patients with conditions unrelated to corneal health or those who do not require corneal transplantation may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could significantly improve the quality and availability of corneal transplants for patients in need.
How similar studies have performed: Previous research has shown promise in cryopreservation techniques, but this specific approach with the IcyEye® kit is novel and has not been extensively tested.
Where this research is happening
COLUMBIA, UNITED STATES
- CRYOCRATE, LLC — COLUMBIA, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: HAN, XU — CRYOCRATE, LLC
- Study coordinator: HAN, XU
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.