Evidence map›Paper›PMID 39135172›Full record

Trial reportStem cell research & therapy2024

Safety and feasibility of intravenous administration of a single dose of allogenic-Muse cells to treat human cervical traumatic spinal cord injury: a clinical trial.

Masao Koda, Shiro Imagama, Hiroaki Nakashima, Sadayuki Ito, Naoki Segi, Jun Ouchida, Kota Suda, Satoko Harmon Matsumoto, Miki Komatsu, Toshiki Endo and 19 more

Erratum issuedAbstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors.

Masao KodaDepartment of Orthopedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan. masaokod@gmail.com.ORCID 0000-0003-0982-5386
Shiro ImagamaDepartment of Orthopaedics/Rheumatology/Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hiroaki NakashimaDepartment of Orthopaedics/Rheumatology/Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Sadayuki ItoDepartment of Orthopaedics/Rheumatology/Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Naoki SegiDepartment of Orthopaedics/Rheumatology/Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Jun OuchidaDepartment of Orthopaedics/Rheumatology/Hand Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Kota SudaHokkaido Spinal Cord Injury Center, Bibai, Japan.
Satoko Harmon MatsumotoHokkaido Spinal Cord Injury Center, Bibai, Japan.
Miki KomatsuHokkaido Spinal Cord Injury Center, Bibai, Japan.
Toshiki EndoDepartment of Neurosurgery, Sendai Medical Center, Sendai, Japan.
Shinsuke SuzukiDepartment of Neurosurgery, Sendai Medical Center, Sendai, Japan.
Satoshi InamiDepartment of Orthopedic Surgery, Dokkyo Medical University, Mibu, Japan.
Haruki UedaDepartment of Orthopedic Surgery, Dokkyo Medical University, Mibu, Japan.
Masayuki MiyagiDepartment of Orthopedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Gen InoueDepartment of Orthopedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Masashi TakasoDepartment of Orthopedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Keiji NagataOrthopedic Surgery, Wakayama Medical University, Wakayama, Japan.
Hiroshi YamadaOrthopedic Surgery, Wakayama Medical University, Wakayama, Japan.
Naosuke KameiDepartment of Orthopaedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Toshio NakamaeDepartment of Orthopaedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Hidenori SuzukiDepartment of Orthopedic Surgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.
Norihiro NishidaDepartment of Orthopedic Surgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.
Masahiro FunabaDepartment of Orthopedic Surgery, Yamaguchi University School of Medicine, Yamaguchi, Japan.
Gentaro KumagaiDepartment of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Takeo FuruyaDepartment of Orthopedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Yu YamatoDepartment of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Toru FunayamaDepartment of Orthopedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroshi TakahashiDepartment of Orthopedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Masashi YamazakiDepartment of Orthopedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSpinal cord injury (SCI) is a devastating injury and remains one of the largest medical and social burdens because of its intractable nature. According to the recent advances in stem cell biology, the possibility of spinal cord regeneration and functional restoration has been suggested by introducing appropriate stem cells. Multilineage-differentiating stress enduring (Muse) cells are a type of nontumorigenic endogenous reparative stem cell. The positive results of Muse cell transplantation for SCI was shown previously. As a first step for clinical application in human SCI, we conducted a clinical trial aiming to confirm the safety and feasibility of intravenously injected donor-Muse cells.

methodsThe study design of the current trial was a prospective, multicenter, nonrandomized, nonblinded, single-arm study. The clinical trial registration number was JRCT1080224764. Patients with a cervical SCI with a neurological level of injury C4 to C7 with the severity of modified Frankel classification B1 and B2 were included. A primary endpoint was set for safety and feasibility. Our protocol was approved by the PMDA, and the trial was funded by the Life Science Institute, Tokyo, Japan. The present clinical trial recruited 10 participants (8 males and 2 females) with an average age of 49.3 ± 21.2 years old. All 10 participants received a single dose of allogenic CL2020 (a total of 15 × 10

resultsThere were two reported severe adverse events, both of which were determined to have no causal relationship with Muse cell treatment. The change in the ISNCSCI motor score, the activity of daily living and quality of life scores showed statistically significant improvements compared to those data at the time of CL2020 administration.

conclusionIn the present trial, no safety concerns were identified, and Muse cell product transplantation demonstrated good tolerability. Future clinical trials with appropriate study designs incorporating a control arm will clarify the definitive efficacy of single-dose allogenic Muse cell treatment with intravenous administration to treat SCI.

trial registrationjRCT, JRCT1080224764. Registered 03 July 2019, https://jrct.niph.go.jp/latest-detail/jRCT1080224764 .

Indexed as

Administration, IntravenousSpinal Cord InjuriesAdultAgedCervical VertebraeFeasibility StudiesFemaleHumansMaleMiddle AgedProspective StudiesClinical trialMuse cellRegenerative therapySpinal cord injury

Identifiers

PMID39135172
PMCPMC11321021

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.