Evidence map›Paper›PMID 29928656›Full record

ArticleAnnals of clinical and translational neurology2018

Long-term Phase 1/2 intraspinal stem cell transplantation outcomes in ALS.

Stephen A Goutman, Morton B Brown, Jonathan D Glass, Nicholas M Boulis, Karl Johe, Tom Hazel, Merit Cudkowicz, Nazem Atassi, Lawrence Borges, Parag G Patil and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of clinical and translational neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
5.6field-weighted citation impact, top 4% of its field
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

35 citing papers in PubMed, 67 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Stem Cell Therapy, the Market, the Opportunities and the Threat.International journal of molecular and cellular medicine · 2023
    Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Stephen A GoutmanDepartment of Neurology University of Michigan 109 Zina Pitcher Place 5017 AAT-BSRB Ann Arbor Michigan 48109.
Morton B BrownDepartment of Biostatistics University of Michigan 1415 Washington Heights M4039 SPH II Ann Arbor Michigan 48109.
Jonathan D GlassDepartment of Neurology Emory University School of Medicine 101 Woodruff Circle Atlanta Georgia 30322.
Nicholas M BoulisDepartment of Neurosurgery Emory University School of Medicine 101 Woodruff Circle WMB Room 6309 Atlanta Georgia.
Karl JoheNeuralstem, Inc. 20271 Goldenrod Lane Suite 2033 Germantown Maryland 20876.
Tom HazelNeuralstem, Inc. 20271 Goldenrod Lane Suite 2033 Germantown Maryland 20876.
Merit CudkowiczDepartment of Neurology Massachusetts General Hospital Harvard Medical School 165 Cambridge Street Boston Massachusetts 02114.
Nazem AtassiDepartment of Neurology Massachusetts General Hospital Harvard Medical School 165 Cambridge Street Boston Massachusetts 02114.
Lawrence BorgesDepartment of Neurosurgery Massachusetts General Hospital Harvard Medical School 15 Parkman Street Wand ACC 745 Boston Massachusetts 02114.
Parag G PatilDepartment of Neurology University of Michigan 109 Zina Pitcher Place 5017 AAT-BSRB Ann Arbor Michigan 48109.
Stacey A SakowskiProgram for Neurology Research and Discovery University of Michigan 109 Zina Pitcher Place 5017 AAT-BSRB Ann Arbor Michigan 48109.
Eva L FeldmanDepartment of Neurology University of Michigan 109 Zina Pitcher Place 5017 AAT-BSRB Ann Arbor Michigan 48109.
University of Michigan–Ann Arbor · USHarvard University · USEmory University · USIntelligent Fusion Technology (United States) · USMassachusetts General Hospital · USNeural Signals (United States) · USWoodruff Health Sciences Center · US

Funding

Phase 1b Trial of stem cells in ALSR01NS077982 · NINDS · EMORY UNIVERSITY · PI BOULIS, NICHOLAS M, FELDMAN, EVA LUCILLE · 2012 to 2015
$2.5M
NINDS NIH HHS R01 NS077982
6 · The paper itself

Abstract

objectiveIntraspinal human spinal cord-derived neural stem cell (HSSC) transplantation is a potential therapy for amyotrophic lateral sclerosis (ALS); however, previous trials lack controls. This post hoc analysis compared ambulatory limb-onset ALS participants in Phase 1 and 2 (Ph1/2) open-label intraspinal HSSC transplantation studies up to 3 years after transplant to matched participants in Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) and ceftriaxone datasets to provide required analyses to inform future clinical trial designs.

methodsSurvival, ALSFRS-R, and a composite statistic (ALS/SURV) combining survival and ALS Functional Rating Scale revised (ALSFRS-R) functional status were assessed for matched participant subsets: PRO-ACT

resultsSurvival did not differ significantly between cohorts: Ph1/2 median survival 4.7 years, 95% CI (1.2, ∞) versus PRO-ACT 2.3 years (1.9, 2.5),

interpretationComparison of Ph1/2 studies to historical datasets revealed significantly improved survival and function using ALS/SURV versus PRO-ACT controls. While results are encouraging, comparison against historical populations demonstrate limitations in noncontrolled studies. These findings support continued evaluation of HSSC transplantation in ALS, support the benefit of control populations, and enable necessary power calculations to design a randomized, sham surgery-controlled efficacy study.

Identifiers

PMID29928656
PMCPMC5989736
OpenAlexW2802819025

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.