# A novel product for tendinopathy treatment

> **NIH NIH R44** · NEW YORK/R&D/CTR/TRANSLATIONAL MED/THER · 2020 · $924,366

## Abstract

Project Summary
Tendinopathy is a tendon disorder characterized by tendon deterioration that often leads to tendon rupture, and
is associated with pain, swelling and impaired performance. There is currently no cure for tendinopathy.
Therefore, there is an urgent need for effective treatments for tendinopathy. Exosomes are specialized
membranous nano-sized extracellular vesicles derived from endocytic compartments that are released by many
cell types. Our initial discovery was that exosomes secreted from tendon derived stem/progenitor cells (TSPCs)
cultured on a novel scaffold, when injected into a tendinopathic tendon, mitigated pathology and pain in a rat
tendinopathy model. We therefore designated the exosomes derived from MSCs cultured on this novel scaffold
as “TenoGen,” and established a project to develop TenoGen as an FDA-approved biologic for tendinopathy
treatment. In our Phase I study, we found that the exosomes derived from human adipose-derived stem cells
(ADSCs) exert an efficacy on tendinopathy that was comparable to that derived from TSPCs, and revealed that
TenoGen produced by TSPCs or ADSCs from aged donors exerts a therapeutic effect on tendinopathy.
Furthermore, we examined and found no general signs of toxicity in the rats treated with TenoGen. These
exciting results in the Phase I study encouraged us to further test our hypothesis that TenoGen exerts a
therapeutic effect in mitigating tendinopathy pathology and relieving tendinopathy-related pain and symptoms
with no or minimal adverse effects. The Phase II study will focus on providing further critical evidence towards
developing TenoGen as an FDA-approved biologic for the autologous or allogeneic treatment of tendinopathy.
We will first determine the efficacy and safety of TenoGen derived from human ADSCs in a tendinopathy model
in nude rats (Aim 1). Specifically, we will first determine the optimal dose and dosing schedule of TenoGen and
determine the efficacy of TenoGen on pathology of tendinopathy. By using the selected optimal dose and optimal
dosing schedule. We will further determine efficacies of TenoGen on improving the mechanical properties of the
diseased tendon, and on relieving pain and behaviors related to tendinopathy. Furthermore, in alignment with
the regulatory requirements for TenoGen as a novel biologic, the safety of human TenoGen will be evaluated in
this immunodeficient animal model. In Aim 2, we will determine the efficacy and safety of TenoGen for
autologous and allogeneic treatment in a tendinopathy model in rabbits, which allows for the evaluation of
TenoGen on tendinopathy in a mid-sized animal model that closely mimics the future treatment protocol in
humans. Successful completion of these studies will provide critical preclinical evidence to support the efficacy
and safety of TenoGen as a biologic for the allogeneic treatment of tendinopathy. The data will be instrumental
for a FDA IND application, and the future R&D towards initiating clinical ...

## Key facts

- **NIH application ID:** 10155342
- **Project number:** 2R44AG056246-02A1
- **Recipient organization:** NEW YORK/R&D/CTR/TRANSLATIONAL MED/THER
- **Principal Investigator:** David T Fung
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $924,366
- **Award type:** 2
- **Project period:** 2017-09-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10155342

## Citation

> US National Institutes of Health, RePORTER application 10155342, A novel product for tendinopathy treatment (2R44AG056246-02A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10155342. Licensed CC0.

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