# Advanced Manufacturing of Regenerative Extracellular Matrix Scaffolds

> **NIH FDA R01** · CARNEGIE-MELLON UNIVERSITY · 2020 · $599,914

## Abstract

The convergence of regenerative and personalized medicine has the potential to revolutionize treatment of a
wide range of diseases and traumatic injuries by harnessing a patient’s own immune system together with
extracellular matrix (ECM) scaffolds to achieve tissue repair. However, the advances being made in academic
research have been slow to translate to the clinic, due in large part to the inability to manufacture these
therapies in a standardized, reproducible and patient-specific manner. The advanced manufacturing of
complex biologic products can solve this problem, serving as the enabling technology for these emerging
applications. Yet while advanced manufacturing of synthetic polymer and titanium implants has already
received FDA-approval, the 3D printing of ECM and cells has proved far more challenging. Here we propose to
develop new technologies critically needed to translate regenerative ECM scaffolds in to the clinic by
addressing key manufacturing needs for ECM scaffold 3D printing. Specifically, we have identified in process
monitoring, multiscale ECM scaffold fabrication and decellularized ECM bioinks as critical capabilities. To do
this we will leverage our expertise in near-IR imaging, decellularized ECM, and 3D biofabrication. The work to
be conducted is summarized in three specific aims. One, to engineer an integrated 3D bioprinting and OCT
imaging system to enable in process monitoring and real-time feedback during biofabrication. The goal of this
aim is to enable nondestructive 3D imaging of ECM scaffolds during the 3D bioprinting process in order to
rapidly assess success/failure. Two, to develop a multi-scale biofabrication process that can combine multiple
3D printing methods in a single construct to recapitulate native tissue composition and architecture. The goal of
this aim is to address the challenge of building large volumetric ECM scaffolds that also require nano- to micro-
scale resolution to form intricate anatomical structures. Three, to establish the ability to 3D bioprint
regenerative ECM scaffolds for volumetric muscle repair, matched to patient-specific anatomical defects. The
goal of this aim is to transition our existing regenerative ECM scaffolds for volumetric muscle repair from a
manual fabrication process to an automated, advanced manufacturing process and use CT and MRI imaging
data to match patient-specific tissue defects. This would have profound consequences by leading towards
clinically-relevant therapeutic strategies to regenerate tissues and develop the advanced manufacturing
capabilities necessary to achieve industrial scale-up and translation.

## Key facts

- **NIH application ID:** 10001351
- **Project number:** 5R01FD006582-03
- **Recipient organization:** CARNEGIE-MELLON UNIVERSITY
- **Principal Investigator:** Stephen F. Badylak
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $599,914
- **Award type:** 5
- **Project period:** 2018-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001351

## Citation

> US National Institutes of Health, RePORTER application 10001351, Advanced Manufacturing of Regenerative Extracellular Matrix Scaffolds (5R01FD006582-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10001351. Licensed CC0.

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