# iPSC-derived cardiac fibroblast extracellular matrix for cardiac cell therapy

> **NIH NIH R43** · CELLULAR LOGISTICS INC. · 2021 · $320,678

## Abstract

Abstract
Cellular Logistics’ (CL) innovation in biomaterials offers a solution to the vexing problem of stem cell retention
and integration in cardiovascular regenerative therapies. Despite great promise and >20 years of research,
regenerative medicine—including stem cell therapies—has yet to demonstrate significant durable regeneration
in the heart. Regenerating damaged heart muscle is a challenging and complex feat—simply providing an
adequate in-situ dose has proven difficult, with <5% of transplanted therapeutic cells retained after 24 hours.
Due to the contractile nature of the heart, transplanted stem cells are rapidly washed out of the tissue, lost to
circulation. Several strategies have been developed as potential solutions, including transplanting cells in
various biomaterials including hydrogels; however, none have proven successful in providing a sufficient in situ
dose to afford durable regeneration. The product of CLI’s proposed SBIR will be the cardiac fibroblast-derived
extracellular matrix (CF-ECM), an injectable acellular biomaterial platform for increasing in-situ stem cell
delivery to the heart. Derived from the culture of human cardiac fibroblasts (CF), CF-ECM has a unique protein
composition to which stem cells naturally attach; CF-ECM also attaches to the myocardium when injected into
the heart, boosting stem cell in-situ dose. The long-term goal of this SBIR is to develop an iPS cardiac
fibroblast (iCF) cell source to support advanced manufacturing and scale up of iCF-ECM. Currently, CL
sources cadaver hearts to isolate primary CF lines; this model can be scaled up to support clinical
manufacturing but iCFs have multiple potential advantages over primary CFs for commercial CF-ECM
production because: (1) genetically defined cell source of unlimited supply; (2) one fully tested master cell bank
with known growth characteristics; (3) expanded replicative capacity (up to passage 17); (4) reduced lot-to-lot
variability of iCF-ECM product; (5) iPSC technology enables genetic modifications, thus allowing for future
product improvements. Furthermore, the iCFs have a more “fetal like” phenotype resulting in ECM generation
more similar to the fetal niche and potentially producing a superior product for regenerative purposes. CLI
hypothesizes that iCF can be used to manufacture iCF-ECM over an expanded passage range and that iCF-
ECM can be used to deliver cardiomyocytes to the infarcted heart. CLI has determined that CF-ECM has
significant commercial opportunity: with ~6 million heart failure patients in the U.S. alone, the estimated market
size for CF-ECM is expected to exceed $2.8B/year. CL’s platform has the potential to improve the therapeutic
effect of cardiac stem cell therapies for HF—an important step toward developing effective measures to stem
the burgeoning HF epidemic.

## Key facts

- **NIH application ID:** 10141127
- **Project number:** 1R43HL156351-01
- **Recipient organization:** CELLULAR LOGISTICS INC.
- **Principal Investigator:** Timothy J. Kamp
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $320,678
- **Award type:** 1
- **Project period:** 2021-02-01 → 2023-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10141127

## Citation

> US National Institutes of Health, RePORTER application 10141127, iPSC-derived cardiac fibroblast extracellular matrix for cardiac cell therapy (1R43HL156351-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10141127. Licensed CC0.

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