Evidence map›Paper›PMID 28199829›Full record

ArticleStem cell reports2017

Preclinical Efficacy Failure of Human CNS-Derived Stem Cells for Use in the Pathway Study of Cervical Spinal Cord Injury.

Aileen J Anderson, Katja M Piltti, Mitra J Hooshmand, Rebecca A Nishi, Brian J Cummings

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cell reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed.

  1. Review
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  9. Article
  10. Review
  11. Article
  12. Cell transplantation to repair the injured spinal cord.International review of neurobiology · 2022
    Article
  13. Review
  14. Review
  15. Review
  16. Current Concepts of Stem Cell Therapy for Chronic Spinal Cord Injury.International journal of molecular sciences · 2021
    Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Aileen J AndersonSue & Bill Gross Stem Cell Center, University of California-Irvine, Irvine, CA 92697, USA; Physical & Medical Rehabilitation, University of California-Irvine, Irvine, CA 92697, USA; Institute for Memory Impairments & Neurological Disorders, University of California-Irvine, Irvine, CA 92697, USA; Anatomy & Neurobiology, University of California-Irvine, Irvine, CA 92697, USA. Electronic address: aja@uci.edu.
Katja M PilttiSue & Bill Gross Stem Cell Center, University of California-Irvine, Irvine, CA 92697, USA; Institute for Memory Impairments & Neurological Disorders, University of California-Irvine, Irvine, CA 92697, USA.
Mitra J HooshmandSue & Bill Gross Stem Cell Center, University of California-Irvine, Irvine, CA 92697, USA; Institute for Memory Impairments & Neurological Disorders, University of California-Irvine, Irvine, CA 92697, USA.
Rebecca A NishiSue & Bill Gross Stem Cell Center, University of California-Irvine, Irvine, CA 92697, USA; Institute for Memory Impairments & Neurological Disorders, University of California-Irvine, Irvine, CA 92697, USA.
Brian J CummingsSue & Bill Gross Stem Cell Center, University of California-Irvine, Irvine, CA 92697, USA; Physical & Medical Rehabilitation, University of California-Irvine, Irvine, CA 92697, USA; Institute for Memory Impairments & Neurological Disorders, University of California-Irvine, Irvine, CA 92697, USA; Anatomy & Neurobiology, University of California-Irvine, Irvine, CA 92697, USA.

Funding

Human neural stem cell therapy for the treatment of cervical spinal cord injury (U01NS079420 · NINDS · UNIVERSITY OF CALIFORNIA-IRVINE · PI ANDERSON, AILEEN J, CUMMINGS, BRIAN JOHN · 2013 to 2015
$2.3M
NINDS NIH HHS U01 NS079420
6 · The paper itself

Abstract

We previously showed the efficacy of multiple research cell lines (RCLs) of human CNS neural stem cells (HuCNS-SCs) in mouse and rat models of thoracic spinal cord injury (SCI), supporting a thoracic SCI clinical trial. Experts recommend in vivo preclinical testing of the intended clinical cell lot/line (CCL) in models with validity for the planned clinical target. We therefore tested the efficacy of two HuCNS-SC lines in cervical SCI: one RCL, and one CCL intended for use in the Pathway Study of cervical SCI in man. We assessed locomotor recovery and sensory function, as well as engraftment, migration, and fate. No evidence of efficacy of the CCL was observed; some data suggested a negative impact of the CCL on outcomes. These data raise questions about the development and validation of potency/comparability assays for clinical testing of cell products, and lack of US Food and Drug Administration requirements for in vivo testing of intended clinical cell lines.

Indexed as

Signal TransductionStem Cell TransplantationAnimalsCell DifferentiationCell LineageCervical CordDisease Models, AnimalFemaleGraft SurvivalHumansLocomotionMiceMotor ActivityNeural Stem CellsRecovery of FunctionSpinal Cord InjuriescervicalefficacyFDA guidelines for cell therapiesgood manufacturing practices (GMP)human neural stem cells (hNSC)RIGORspinal cord injury (SCI)

Identifiers

PMID28199829
PMCPMC5312249

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.