Evidence map›Paper›PMID 35613802›Full record

Trial reportBMJ open2022

Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR).

Satoshi Suda, Chikako Nito, Masafumi Ihara, Yasuyuki Iguchi, Takao Urabe, Yuji Matsumaru, Nobuyuki Sakai, Kazumi Kimura, J- REPAIR trial group

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04608838 (An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT04608838 phase1 / phase2completednot on this map

An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke

TypeinterventionalSponsorTeijin Pharma LimitedRan2019 to 2021Enrolled79ConditionsAcute Ischemic StrokeArmsJTR-161, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Molecular imaging of stem cell therapies in ischemic stroke.European journal of nuclear medicine and molecular imaging · 2025
    Review
  7. [Biological characteristics and translational research of dental stem cells].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2025
    Review
  8. Review
  9. The Therapeutic Scope of Orofacial Mesenchymal Stem Cells.Bioengineering (Basel, Switzerland) · 2025
    Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. An update on stem cell therapy for stroke patients: Where are we now?Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2024
    Review
  17. Article
  18. Review
  19. Review
  20. Research progress on optimization ofFrontiers in bioengineering and biotechnology · 2024
    Review
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 6 institutions in 1 country.

Satoshi Suda *Department of Neurology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan.ORCID 0000-0002-7242-2005
Chikako Nito *Department of Neurology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan cnito@nms.ac.jp.
Masafumi IharaNeurology, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.ORCID 0000-0002-7102-4048
Yasuyuki IguchiDepartment of Neurology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.
Takao UrabeDepartment of Neurology, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.
Yuji MatsumaruDepartment of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Nobuyuki SakaiDepartment of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Kazumi KimuraDepartment of Neurology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan.
J- REPAIR trial group
Nippon Medical School · JPJikei University School of Medicine · JPJuntendo University Urayasu Hospital · JPKobe City Medical Center General Hospital · JPNational Cerebral and Cardiovascular Center · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionJTR-161 is a novel allogeneic human cell product consisting of dental pulp stem cells isolated from the extracted teeth of healthy adults. It is currently under development as a cell-based therapy for ischaemic stroke. The aim of this study is to evaluate the safety and efficacy of JTR-161 in patients with acute ischaemic stroke when given as a single intravenous administration within 48 hours of symptom onset. METHODS AND ANALYSIS: This is a first-in-human, randomised, double-blind, placebo-controlled, multicentre, phase 1/2 clinical trial to be conducted in Japan (from January 2019 to July 2021). Patients with a clinical diagnosis of anterior circulation ischaemic stroke with a National Institutes of Health Stroke Scale (NIHSS)score of 5-20 at baseline were enrolled. Patients previously treated with recombinant tissue-type plasminogen activator and/or endovascular thrombectomy were allowed to be enrolled. The study consists of three cohorts: cohorts 1 and 2 (each eight patients) and cohort 3 (60 patients). Subjects were randomly assigned to receive either JTR-161 or placebo in a 3:1 ratio in cohorts 1 and 2, and in a 1:1 ratio in cohort 3. The number of cells administered was increased sequentially from 1×10 ETHICS AND DISSEMINATION: The protocol and informed consent form were approved by the institutional review board at each participating study site. A manuscript with the results of the primary study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04608838; JapicCTI-194570 and Clinical Trials. gov.

Indexed as

Brain IschemiaHematopoietic Stem Cell TransplantationIschemic StrokeStrokeAdultDental PulpDouble-Blind MethodHumansTreatment OutcomeINTERNAL MEDICINENeurologyNEUROLOGYStroke

Identifiers

PMID35613802
PMCPMC9125710
OpenAlexW4281485139

What OpenQuestion holds

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LicenceCC BY-NC
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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.