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Long-term safety and clinical outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic cervical spinal cord injury.

Overview

Authors: Mickey E Abraham1, Joel R Martin2, Margaret Seaton1, Michael G Brandel1, Kiefer J Forseth1, Catriona Jamieson3, Martin Marsala4, Joseph D Ciacci1
  1. Department of Neurological Surgery, University of California, San Diego, La Jolla, CA 92037, USA
  2. Department of Neurological Surgery, Orlando Health, Orlando, FL 32806, USA
  3. Department of Medicine, Division of Regenerative Medicine and CIRM Alpha Stem Cell Clinic, University of California, San Diego, La Jolla, CA 92037, USA
  4. Department of Anesthesiology, University of California, San Diego, La Jolla, CA 92037, USA
Institutions: University of California San Diego (United States); Orlando Health (United States)
Journal: Stem cell reports, volume 21, issue 6, article 102926
Dates: received 25 September 2025; accepted 19 April 2026; published online 21 May 2026; in print June 2026
Type: Research article · Language: English
License: CC BY
Identifiers: DOI 10.1016/j.stemcr.2026.102926 · PMID 42167221 · PMCID PMC13261865 · OpenAlex W7161998720
Open access: gold, a free copy (OpenAlex)
Status: code on request
Categories: human (organism), other condition (population)
Methods: Physiology & signal measures
Keywords: spinal cord injury, stem cells, neural stem cells, intraspinal, clinical trial, spine
MeSH: Cervical Cord*, Neural Stem Cells*, Spinal Cord Injuries*, Stem Cell Transplantation*, Adult, Cervical Vertebrae, Chronic Disease, Humans, Male, Middle Aged, Recovery of Function, Treatment Outcome, Young Adult (* major topic)
Topic: Nerve injury and regeneration (Cellular and Molecular Neuroscience, Neuroscience), according to OpenAlex
Funding: Clinical Center; University of California, San Diego
Citations: not cited yet (Europe PMC); 41 references in the paper

Abstract

Neural stem cell transplantation offers a promising avenue for spinal cord injury (SCI) repair, but demonstrating safety and feasibility in human populations remains a critical step. In this phase 1 trial, we investigate the long-term outcomes of cervical spinal cord implantation of NSI-566, a human spinal cord-derived neural stem cell line. With prospective data collection over 60 months, we assess adverse events, functional outcomes, and neurophysiological measures in a small cohort (N = 3) of chronic AIS-A SCI patients. We report a favorable safety profile with no evidence of tumorigenicity or procedure-related complications. Subclinical neurophysiological changes and limited functional gains were observed, although interpretation is constrained by the absence of a control group and the confounding effects of post-operative rehabilitation. These findings support the feasibility of intraparenchymal stem cell delivery for chronic SCI and underscore the need for larger, controlled trials to clarify efficacy and optimize therapeutic parameters.

Reproduced under the paper's license (CC BY), from the paper cited above.

Code

The paper says that its authors' code is available on request: it was not published with the paper, so there is nothing to verify.

The paper's code and data availability statement is in the Data section.

Tracing map

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Data

No dataset and no data link were found in the paper.

Data and code availability

No new custom code was generated in this study; however, the scripts used for data analysis are available from the corresponding author upon reasonable request.

Reproduced under the paper's license (CC BY), from the paper cited above.

Versions

The history of this record: each version stored by the harvester or made by a correction of its authors or of the maintainers of its code, and what changed in its facts. The texts of the paper (its abstract, its availability statements) are not part of it; versions that changed only those are not listed.

Version 1, 28 September 2026: the first record

Recorded: type, language, journal, volume, issue, pages, dates, 8 authors, 6 keywords, 13 MeSH terms, 2 funders, 40 references.

Cite

This paper

Abraham, M. E., Martin, J. R., Seaton, M., Brandel, M. G., Forseth, K. J., Jamieson, C., Marsala, M., & Ciacci, J. D. (2026). Long-term safety and clinical outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic cervical spinal cord injury. Stem cell reports, 21(6), 102926. https://doi.org/10.1016/j.stemcr.2026.102926

BibTeX

@article{abraham2026long,
author = {Abraham, Mickey E and Martin, Joel R and Seaton, Margaret and Brandel, Michael G and Forseth, Kiefer J and Jamieson, Catriona and Marsala, Martin and Ciacci, Joseph D},
title = {{Long-term safety and clinical outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic cervical spinal cord injury}},
journal = {Stem cell reports},
year = {2026},
month = may,
volume = {21},
number = {6},
pages = {102926},
publisher = {Elsevier},
issn = {2213-6711},
doi = {10.1016/j.stemcr.2026.102926},
url = {https://doi.org/10.1016/j.stemcr.2026.102926},
pmid = {42167221},
pmcid = {PMC13261865}
}

RIS

TY - JOUR
AU - Abraham, Mickey E
AU - Martin, Joel R
AU - Seaton, Margaret
AU - Brandel, Michael G
AU - Forseth, Kiefer J
AU - Jamieson, Catriona
AU - Marsala, Martin
AU - Ciacci, Joseph D
TI - Long-term safety and clinical outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic cervical spinal cord injury
T2 - Stem cell reports
J2 - Stem Cell Reports
PY - 2026
DA - 2026/05/21
VL - 21
IS - 6
SP - 102926
SN - 2213-6711
PB - Elsevier
DO - 10.1016/j.stemcr.2026.102926
UR - https://doi.org/10.1016/j.stemcr.2026.102926
LA - en
ER -

CSL-JSON

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"container-title": "Stem cell reports",
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