# Tuned stem cell extracellular vesicles are a novel chronic wound therapeutic

> **NIH NIH R44** · ZEN-BIO, INC. · 2020 · $1,183,225

## Abstract

Project Summary
The elderly population is rapidly increasing worldwide and those over 60 years old are expected to comprise 20% of the
total population by 2050. These demographic changes will focus healthcare needs on those conditions more prevalent in
the elderly. Chronic wounds, such as venous leg ulcers, pressure ulcers and diabetic ulcers are over-represented in the
elderly population and even now present a significant healthcare burden. These conditions impact approximately 6.5
million patients annually with a cost to the health care system of over $25B. Rarely occurring in the young, the healing of
these chronic wounds is confounded by age-related factors such as reduced blood flow, dermal atrophy, increased
inflammation and reduced growth factor responses. The high recurrence rate and failure to respond to current therapies
indicates the need for improved regenerative therapeutics that can overcome many of the age-associated defects in the
wound healing process. Stem cell therapies represent a compelling means of tissue repair and have demonstrated wound
healing and soft tissue regeneration in animal models. However, the intuitive concept that therapeutic stem cells engraft
and differentiate at sites of tissue damage is not well supported given the low numbers of cells retained over time at
application sites in vivo. This suggests that their mechanisms of action occur through paracrine modalities such as
secretion of bioactive vesicles, including exosomes. Hence, exploiting stem cell-derived exosomes as a biologic-derived
therapy, rather than delivering transient stem cells to treat chronic wounds, is an enticing approach. Secreted extracellular
vesicles (EVs), such as exosomes, are packed with potent pro-repair proteins and RNA cargos that are both cell type-
specific, as well as, differentially produced and secreted according to the cellular environment. Based on our successful
Phase I project, this Phase II program will continue the development and manufacturing of stem cell-derived EVs
specifically produced as a chronic wound therapeutic. We will achieve this goal by the following Aims: 1) Optimize the
production of selectively-modified hASC EVs for chronic wound healing, 2) In vivo testing of EVs in chronic wound
models to establish optimal dosing and route of administration, and 3) Initiate IND enabling studies. This Phase II
research program is designed to identify an optimal manufacturing method of bioactive EVs with in vitro and in vivo
efficacy and potency, minimal toxicity and strong clinical and translational potential for the treatment of age-related
chronic wounds towards a future IND submission. This potential therapeutic has the unique advantage of harnessing the
power of stem cells without the need for utilizing complex cell therapies.

## Key facts

- **NIH application ID:** 10022443
- **Project number:** 5R44AG058351-03
- **Recipient organization:** ZEN-BIO, INC.
- **Principal Investigator:** YOLANDA Renee LEA-CURRIE
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,183,225
- **Award type:** 5
- **Project period:** 2017-09-15 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10022443

## Citation

> US National Institutes of Health, RePORTER application 10022443, Tuned stem cell extracellular vesicles are a novel chronic wound therapeutic (5R44AG058351-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10022443. Licensed CC0.

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