Evidence map›Paper›PMID 30048006›Full record

ArticleAnnals of neurology2018

Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis.

Ki-Wook Oh, Min-Young Noh, Min-Soo Kwon, Hyun Young Kim, Seong-Il Oh, Jinseok Park, Hee-Jin Kim, Chang-Seok Ki, Seung Hyun Kim

3 registry-linked trialsOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 74 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 5 pooled it
8.3field-weighted citation impact, top 2% 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.

NCT01363401 phase1 / phase2completednot on this map

An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

TypeinterventionalSponsorCorestemchemon, Inc.Ran2011 to 2013Enrolled72ConditionsAmyotrophic Lateral Sclerosis, ALSArmsHYNR-CS inj, Control group
NCT05003921 phase1suspendednot on this mapstarted 2025, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2025 to 2028Enrolled20ConditionsAmyotrophic Lateral SclerosisArmsAlloRx
NCT05695521 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial

TypeinterventionalSponsorCellenkos, Inc.Ran2023 to 2027Enrolled66ConditionsAmyotrophic Lateral SclerosisArmsCK0803, Excipient
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 5 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Guideline
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  4. Cell-based therapies for amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2019
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  7. Repeat Administration of Bone Marrow-Derived Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis.Medical science monitor : international medical journal of experimental and clinical research · 2020
    Trial
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14 more citing papers are in PubMed but not listed here.

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

9 authors at 5 institutions in 1 country.

Ki-Wook OhDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Min-Young NohDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Min-Soo KwonDepartment of Pharmacology, School of Medicine, CHA University, Gyeonggi-do.
Hyun Young KimDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Seong-Il OhDepartment of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan.
Jinseok ParkDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Hee-Jin KimDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Chang-Seok KiDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Seung Hyun KimDepartment of Neurology, College of Medicine, Hanyang University, Seoul.
Hanyang University · KRHanyang University Seoul Hospital · KRCHA University · KRInje University Busan Paik Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety and efficacy of 2 repeated intrathecal injections of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) in amyotrophic lateral sclerosis (ALS).

methodsIn a phase 2 randomized controlled trial (NCT01363401), 64 participants with ALS were randomly assigned treatments (1:1) of riluzole alone (control group, n = 31) or combined with 2 BM-MSC injections (MSC group, n = 33). Safety was assessed based on the occurrence of adverse events. The primary efficacy outcome was changes in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score from baseline to 4 and 6 months postinjection. Post hoc analysis includes investigation of cerebrospinal fluid biomarkers and long-term survival analysis.

resultsSafety rating showed no groupwise difference with absence of serious treatment-related adverse events. Mean changes in ALSFRS-R scores from baseline to 4 and 6 months postinjection were reduced in the MSC group compared with the control group (4 months: 2.98, 95% confidence interval [CI] = 1.48-4.47, p < 0.001; 6 months: 3.38, 95% CI = 1.23-5.54, p = 0.003). The MSC group showed decreased proinflammatory and increased anti-inflammatory cytokines. In good responders, transforming growth factor β1 significantly showed inverse correlation with monocyte chemoattractant protein-1. There was no significant difference in long-term survival between groups.

interpretationRepeated intrathecal injections of BM-MSCs demonstrated a possible clinical benefit lasting at least 6 months, with safety, in ALS patients. A plausible action mechanism is that BM-MSCs mediate switching from pro- to anti-inflammatory conditions. A future randomized, double-blind, large-scale phase 3 clinical trial with additional BM-MSC treatments is required to evaluate long-term efficacy and safety. Ann Neurol 2018;84:361-373.

Indexed as

Cell- and Tissue-Based TherapyMesenchymal Stem Cell TransplantationAdultAgedAmyotrophic Lateral SclerosisBiomarkersCytokinesDouble-Blind MethodFemaleHumansMaleMesenchymal Stem CellsMiddle AgedBiomarkersCytokines

Identifiers

PMID30048006
PMCPMC6175096
OpenAlexW2884205788

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.