Evidence map›Paper›PMID 26608364›Full record

Trial reportInternational journal of hematology2016

Bone marrow-derived mesenchymal stem cells (JR-031) for steroid-refractory grade III or IV acute graft-versus-host disease: a phase II/III study.

Kazuo Muroi, Koichi Miyamura, Masaya Okada, Takuya Yamashita, Makoto Murata, Takayuki Ishikawa, Naokuni Uike, Michihiro Hidaka, Ryoji Kobayashi, Masahiro Imamura and 8 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 2 pooled it
5.5field-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.

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

82 citing papers in PubMed, 2 syntheses or guidelines pooled it, 158 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Baseline CD4Journal of blood medicine · 2025
    Trial
  5. Trial
  6. A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020
    Trial
  7. Trial
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Mesenchymal stromal cell therapy: Progress to date and future outlook.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  16. Review
  17. Increasing robustness ofRegenerative therapy · 2025
    Article
  18. Article
  19. Review
  20. Review

22 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

18 authors at 15 institutions in 1 country.

Kazuo MuroiDivision of Cell Transplantation and Transfusion, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. muroi-kz@jichi.ac.jp.
Koichi MiyamuraDepartment of Hematology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Masaya OkadaDivision of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Takuya YamashitaDepartment of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
Makoto MurataDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Takayuki IshikawaKobe City Medical Center General Hospital, Kobe, Japan.
Naokuni UikeNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization, Kumamoto Medical Center, Kumamoto, Japan.
Ryoji KobayashiDepartment of Pediatrics, Sappro Hokuyu Hospital, Sapporo, Japan.
Masahiro ImamuraStem Cell Transplantation Center, Hokkaido University Hospital, Sapporo, Japan.
Junji TanakaDepartment of Hematology, Tokyo Women's Medical University, Tokyo, Japan.
Kazuteru OhashiHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Shuichi TaniguchiDepartment of Hematology, Toranomon Hospital, Tokyo, Japan.
Takashi IkedaDivision of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, Nagaizumi-cho, Japan.
Tetsuya EtoDepartment of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
Masaki MoriDivision of Hematology, Department of Medicine, Jichi Medical University, Shimotsuke, Japan.
Mariko YamaokaData Science Group, Clinical Intelligence Department, Development Division, JCR Pharmaceuticals Co., Ltd, Ashiya, Japan.
Keiya OzawaDivision of Genetic Therapeutics, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Jichi Medical University · JPHamanomachi Hospital · JPHokkaido University Hospital · JPHyogo Medical University · JPJCR Pharmaceuticals (Japan) · JPKobe City Medical Center General Hospital · JPKumamoto Medical Center · JPNagoya University · JPNational Hospital Organization Kyushu Cancer Center · JPSapporo Hokuyu Hospital · JPShizuoka Cancer Center · JPThe University of Tokyo · JPTokyo Metropolitan Komagome Hospital · JPTokyo Women's Medical University · JPToranomon Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Following a phase I/II study using mesenchymal stem cells (MSCs; JR-031) for steroid-refractory grade II or III acute graft-versus-host disease (aGVHD), a phase II/III study using the cells focused on steroid-refractory grade III or IV aGVHD was conducted. The number of infused MSCs and the number of MSC infusions were the same as the phase I/II study. No additional immunosuppressant was given for steroid-refractory aGVHD during the course of MSC infusions. Twenty-five patients (grade III, 22 patients and grade IV, 3 patients) were enrolled in this study. At 4 weeks after the first MSC infusions, six (24 %) and nine patients (36 %) achieved a complete response (CR) and partial response (PR), respectively. Durable CR by 24 weeks, which was the primary end-point, was obtained in 12 of 25 patients (48 %). At 52 weeks, 12 patients (48 %) treated with MSCs only (six patients) and MSCs plus additional treatments (six patients) were alive in CR. The survival was significantly better in patients showing overall response (OR; CR+PR) than in those showing no OR at 4 weeks. Adverse effects commonly associated with MSC infusions were not observed. Taken together, our two clinical trials suggest JR-031 to be effective for steroid-refractory aGVHD.

Indexed as

Mesenchymal Stem Cell TransplantationAcute DiseaseAdolescentAdultAgedChildChild, PreschoolFemaleGraft vs Host DiseaseHumansMaleMethylprednisoloneMiddle AgedPrednisoloneSeverity of Illness IndexTreatment FailureMethylprednisolonePrednisoloneGVHDMesenchymal stem cellsSteroid

Identifiers

PMID26608364
OpenAlexW2174299838

What OpenQuestion holds

Textmetadata
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.