# Evaluation of Hyaleo pre-clinical safety and efficacy for healing large cartilage defects in the knee

> **NIH NIH R43** · CARTILAGE INC. · 2020 · $252,131

## Abstract

PROJECT SUMMARY
The goal of this proposal is to evaluate the safety and efficacy of HyaleonTM to heal large defects in the knee in
a pre-clinical large animal model. HyaleonTM is an allogeneic neocartilage implant that exhibits biomimetic
properties, for example, biomechanical properties on par with native cartilage. It is derived from juvenile rib
cartilage and it is engineered specifically to address the healing of large defects, in contrast to current clinical
approaches (e.g., microfracture, chondroplasty, and mosaicplasty) which address only small defects. Cell-based
treatments are emerging as alternatives to current clinical approaches. However, obtaining sufficient cell
numbers, maintaining functionality of the cells, and donor site morbidity are significant obstacles to successful
clinical outcomes of cell-based approaches. To address these shortcomings, Cartilage Inc., an all women-run
company, developed HyaleonTM using novel, patent-pending platform technologies, Apeira-cellsTM and NeotisTM.
Apeira-cellsTM and NeotisTM enable the production of mechanically robust, scaffold-free engineered neocartilage
from an abundance of pure, functional cells obtained from a miniscule amount of donor tissue. Unlike current
treatments, HyaleonTM produces native-like repair cartilage and is not limited by cell scarcity, donor site morbidity,
or poor functionality of cells. HyaleonTM utilizes juvenile costal chondrocytes that are highly passaged (up to
passage 9). Costal cartilage is more readily available than healthy articular cartilage, rendering it an attractive
alternative cell source for tissue-engineered products. Toward collecting critical pre-clinical data that will
contribute to an Investigational New Drug (IND) application to the Food & Drug Administration (FDA), this
proposal aims to evaluate the safety and efficacy of HyaleonTM to heal large cartilage defects in vivo. According
to FDA guidance documents, due to immunological reactions of human products in animals, pre-clinical studies
need to be performed using animal cellular products that are analogous to the intended human clinical products.
Thus, Aim 1 focuses on generating an analogous animal cellular product (Hyaleon-MP) using HyaleonTM
technology (i.e., Apeira-cellsTM and NeotisTM) for investigation in Aim 2’s pre-clinical animal study. Aim 2 focuses
on evaluating the safety and efficacy of Hyaleon-MP to heal large knee articular cartilage defects in the minipig.
Completion of this proposal will provide a solid foundation for HyaleonTM as a promising solution for cartilage
repair. Next steps include validating the long-term (6-12 months) in vivo safety and efficacy of HyaleonTM in
definitive pre-clinical large animal studies, establishing GMP-compliant processes to manufacture HyaleonTM,
and creating a GMP-compliant allogeneic cell bank for the production of HyaleonTM. Data generated from these
aims will contribute to a submission to the FDA to begin clinical investigation of HyaleonT...

## Key facts

- **NIH application ID:** 10076405
- **Project number:** 1R43AR077461-01A1
- **Recipient organization:** CARTILAGE INC.
- **Principal Investigator:** Wendy E. Brown
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $252,131
- **Award type:** 1
- **Project period:** 2020-09-03 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10076405

## Citation

> US National Institutes of Health, RePORTER application 10076405, Evaluation of Hyaleo pre-clinical safety and efficacy for healing large cartilage defects in the knee (1R43AR077461-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10076405. Licensed CC0.

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