# Advancing human neural progenitor cells (hNPCs) to FDA IND approval

> **NIH VA IU1** · VA SAN DIEGO HEALTHCARE SYSTEM · 2023 · —

## Abstract

Our work to date has demonstrated that Neural Progenitor Cells (NPCs) and Neural Stem Cells
(NSCs) survive grafting to the spinal cord and extend very large numbers of axons over long
distances through the lesioned rodent and non-human primate (NHP) spinal cord. Host axons
also regenerate into cell grafts occupying the lesion site, and form new synaptic connections
that act as neural relays across the injury to support functional improvement in both rodents and
primates. We have identified a lead candidate human NSC/NPC line for clinical translation: an
H9 human embryonic stem cell (a federally approved human cell line) that is driven to a spinal
cord NSC/NPC fate. We refer to these cells as H9-scNSCs. H9-scNSCs survive grafting to
rhesus monkey cervical spinal cord hemisection and contusion lesions. This promising line of
work is advancing on a translational path, supported extensively by the VA’s RR&D Gordon
Mansfield Spinal Cord Injury Consortium. We aim to bring this work to the point of readiness for
human clinical trials in both subacute SCI and, subsequently, chronic SCI. In addition, our
ongoing work in the Consortium aims to improve the potency of this intervention through
combinations with rehabilitation and neuromodulation (e.g., targeted epidural spinal stimulation).
The goal of the current application is to advance this program to submission of an FDA pre-IND,
with the eventual goal of a human clinical trial of this promising approach. For the one-year
funding period, this project will support project management (75% effort) and the services of a
regulatory expert with experience in FDA submissions.

## Key facts

- **NIH application ID:** 10642228
- **Project number:** 1IU1RX004569-01
- **Recipient organization:** VA SAN DIEGO HEALTHCARE SYSTEM
- **Principal Investigator:** MARK H. TUSZYNSKI
- **Activity code:** IU1 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2023
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2023-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10642228

## Citation

> US National Institutes of Health, RePORTER application 10642228, Advancing human neural progenitor cells (hNPCs) to FDA IND approval (1IU1RX004569-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10642228. Licensed CC0.

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