# Pre-clinical validation of 3D-printed nerve conduits for pediatric peripheral nerve repair

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $525,843

## Abstract

Project Summary
Peripheral nerve injuries, as a result of trauma, tumors, or other medical conditions, require 50,000-200,000
surgeries annually, and may cause complete or partial paralysis. The autograft is the current "gold standard"
but requires additional procedures to harvest the graft, can be challenging to perform in a pediatric population,
and often leads to neuroma formation and loss of function at the donor site. The goal of this project is to validate
the materials and methods to fabricate pre-clinical polymeric three-dimensional (3D) nerve conduits with an
embedded wireless sensor for continuous monitoring of functional recovery to be used in infants/children. The
3D printed vascularizable nerve conduits mimic the micro-architecture of nerve tissues, are embedded with
wireless sensors for in situ monitoring, and can perform biomimetic functions to augment nerve regeneration
therapies. Currently, there is no clinical solution for monitoring the success of a neural graft therapy after
surgery. Specific Aim 1 will focus on optimizing 3D-bioprinted nerve conduit fabrication and performance using
commercial-grade biomaterials for clinical translation. To fabricate such a conduit in this aim, we will use a
Rapid Projection, Image-guided, Direct-printing (RaPID) platform that can 3D-print the entire nerve conduit in
mere seconds and will match the patient’s specific size and shape. The conduit will have linear micro-channels
along the length for axon growth and side micro-holes for vascularization. Specific Aim 2 will validate generation
of pediatric patient-specific conduits based on volumetric defect. In this aim, we will coordinate the collection of
MRI data among pediatric patients from birth to 18 years of age, both sexes, and with peripheral nerve injuries
involving the head and neck, upper limbs, and lower limbs. Based upon the MRI data collected, personalized
pediatric nerve conduits will be 3D bioprinted to validate the RaPID system and provide evidence for planned
FDA regulatory review. Specific Aim 3 will develop a wirelessly powered and controlled sensor to detect
electrical impulses across a nerve defect. In this aim, we will attach wireless sensors via a polymeric cuff design
to the distal end of an injured mouse sciatic nerve to assess the rate and robustness of nerve fiber growth
across the therapeutic repair site. Developing this implantable sensor will pave the way for integrating
diagnostics with therapeutics for surgical interventions. The final deliverable at the completion of this proposal
will be to have the manufacturing specifications, source material specifications, sizing limits, testing and release
specifications for 3D bioprinted nerve conduits with wireless sensing to support a pre-submission meeting with
FDA followed by a 510(k) filing.

## Key facts

- **NIH application ID:** 10876494
- **Project number:** 5R01HD112026-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** SHAOCHEN CHEN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $525,843
- **Award type:** 5
- **Project period:** 2023-06-27 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10876494

## Citation

> US National Institutes of Health, RePORTER application 10876494, Pre-clinical validation of 3D-printed nerve conduits for pediatric peripheral nerve repair (5R01HD112026-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10876494. Licensed CC0.

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