Evidence map›Paper›PMID 30670057›Full record

Trial reportArthritis research & therapy2019

CD34-selected versus unmanipulated autologous haematopoietic stem cell transplantation in the treatment of severe systemic sclerosis: a post hoc analysis of a phase I/II clinical trial conducted in Japan.

Masahiro Ayano, Hiroshi Tsukamoto, Hiroki Mitoma, Yasutaka Kimoto, Mitsuteru Akahoshi, Yojiro Arinobu, Toshihiro Miyamoto, Takahiko Horiuchi, Hiroaki Niiro, Koji Nagafuji and 2 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025
    Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Stem cell-based therapy for systemic sclerosis.Rheumatology advances in practice · 2023
    Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Systemic sclerosis (scleroderma): remaining challenges.Annals of translational medicine · 2021
    Review
  14. Hematopoietic stem cell transplantation in systemic sclerosis: Yes!! BUT. . .Journal of scleroderma and related disorders · 2021
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

12 authors at 3 institutions in 1 country.

Masahiro AyanoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. m-ayano@intmed1.med.kyushu-u.ac.jp.
Hiroshi TsukamotoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Hiroki MitomaDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Yasutaka KimotoDepartment of Internal Medicine, Kyushu University Beppu Hospital, 4546 Tsurumibaru, Tsurumi, Beppu, 874-0838, Japan.
Mitsuteru AkahoshiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Yojiro ArinobuDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Toshihiro MiyamotoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Takahiko HoriuchiDepartment of Internal Medicine, Kyushu University Beppu Hospital, 4546 Tsurumibaru, Tsurumi, Beppu, 874-0838, Japan.
Hiroaki NiiroDepartment of Medical Education, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Koji NagafujiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Mine HaradaDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Kyushu University · JPKyushu University Beppu Hospital · JPJapan Medical Association · JP

Funding

Japan Agency for Medical Research and Development the Practical Research Project for Rare/Intractable DiseasesJapan Society for the Promotion of Science JSPS KAKENHI 15K09527Japan Society for the Promotion of Science JSPS KAKENHI 16K19603Ministry of Health, Labour and Welfare H24-Jitsuyoka-Kokusai-004
6 · The paper itself

Abstract

backgroundThe effectiveness of autologous haematopoietic stem cell transplantation (auto-HSCT) in treating severe systemic sclerosis (SSc) is established; however, the necessity of purified CD34+ cell grafts and the appropriate conditioning regimen remain unclear. This study aimed to compare the efficacy and safety of CD34-selected auto-HSCT with unmanipulated auto-HSCT to treat severe SSc.

methodsThis study was a post hoc analysis of a phase I/II clinical trial conducted in Japan. Nineteen patients with severe SSc were enrolled. Peripheral blood stem cells (PBSCs) were mobilised with cyclophosphamide (4 g/m

resultsSkin sclerosis progressively improved after transplantation over an 8-year follow-up period in both groups, and the improvement was significantly greater in the CD34-selected group than in the unmanipulated group. Forced vital capacity in the CD34-selected group continuously increased over 8 years, whereas in the unmanipulated group it returned to baseline 3 years after transplantation. Toxicity and viral infections, such as cytomegalovirus infection and herpes zoster, were more frequently found in the CD34-selected group than in the unmanipulated group. The frequency of severe adverse events, such as bacterial infections or organ toxicity, was similar between the two groups. No treatment-related deaths occurred in either treatment group. PFS of the CD34-selected group was greater than that of the unmanipulated group, and the 5-year PFS rates of the CD34-selected and unmanipulated group were 81.8% and 50% respectively.

conclusionsCD34-selected auto-HSCT may produce favourable effects on improvement of skin sclerosis and pulmonary function compared with unmanipulated auto-HSCT. Use of CD34-selected auto-HSCT with high-dose cyclophosphamide monotherapy as a conditioning regimen may offer an excellent benefit-to-risk balance.

Indexed as

AdultAntigens, CD34CyclophosphamideDisease-Free SurvivalFemaleHematopoietic Stem CellsHematopoietic Stem Cell TransplantationHumansImmunosuppressive AgentsJapanMaleMiddle AgedOutcome Assessment, Health CareScleroderma, SystemicSeverity of Illness IndexTransplantation, AutologousAntigens, CD34CyclophosphamideImmunosuppressive AgentsCD34Haematopoietic stem cell transplantationSclerodermaSystemic sclerosis

Identifiers

PMID30670057
PMCPMC6341635
OpenAlexW2917444176

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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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.