Evidence map›Paper›PMID 16126798›Full record

Trial reportAnnals of the rheumatic diseases2006

A phase I-II trial of autologous peripheral blood stem cell transplantation in the treatment of refractory autoimmune disease.

H Tsukamoto, K Nagafuji, T Horiuchi, T Miyamoto, K Aoki, K Takase, H Henzan, D Himeji, T Koyama, K Miyake and 6 more

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

Trial report in Annals of the rheumatic diseases, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% 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, 2 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Article
  5. Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Stem cell-based therapy for systemic sclerosis.Rheumatology advances in practice · 2023
    Review
  11. Stem Cell Therapy in Lupus.Rheumatology and immunology research · 2022
    Review
  12. Review
  13. Article
  14. Review
  15. Stem cell autograft and allograft in autoimmune diseases.Clinical and experimental medicine · 2016
    Review
  16. Scleroderma lung disease.European respiratory review : an official journal of the European Respiratory Society · 2013
    Review
  17. Review
  18. Recent advances in the treatment of systemic sclerosis.Clinical reviews in allergy & immunology · 2009
    Review
  19. Article
  20. Article
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

16 authors at 3 institutions in 1 country.

H TsukamotoMedicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. tsukamot@intmed1.med.kyushu-u.ac.jp
K Nagafuji
T Horiuchi
T Miyamoto
K Aoki
K Takase
H Henzan
D Himeji
T Koyama
K Miyake
Y Inoue
H Nakashima
T Otsuka
Y Tanaka
K Nagasawa
M Harada
Kyushu University · JPSaga University · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo carry out a phase I-II trial to elucidate the feasibility and efficacy of high dose cyclophosphamide (CY) supported by autologous peripheral blood stem cell transplantation (PBSCT) in the treatment of severe and refractory autoimmune disease (AD).

methodsPeripheral blood stem cells (PBSCs) were mobilised during haematological recovery after relatively high dose CY (2 g/m2) for 2 days, followed by administration of granulocyte colony stimulating factor. After collecting PBSCs--more than 2x10(6) CD34+ cells/kg--by apheresis, CD34+ cells were immunologically selected and cryopreserved. Eight patients were enrolled--five had systemic sclerosis (SSc) alone, one had SSc with systemic lupus erythematosus, one amyopathic dermatomyositis (ADM), and one Wegener's granulomatosis (WG). All of the patients were treated with high dose CY (50 mg/kg) for 4 days and autologous PBSCT.

resultsHaematopoietic reconstitution was rapid and sustained. Toxicity due to the regimen included various infections such as pneumonia, sepsis, cystitis, herpes zoster, and acute heart failure. However, there was no treatment related mortality. Encouraging results were obtained after autologous PBSCT. Sclerosis of the skin was markedly improved in all of the patients with SSc. Interstitial pneumonia (IP), evaluated by PaO2, serum KL-6 levels, and pulmonary high resolution computed tomography, improved significantly. In a patient with ADM, severe and progressive IP also improved markedly. In a patient with WG, the size of the left orbital granuloma decreased substantially, resulting in reduction of the exophthalmos.

conclusionsThese observations suggest that high dose CY with autologous PBSCT is feasible and may be effective in the treatment of severe and refractory AD.

Indexed as

Peripheral Blood Stem Cell TransplantationAdultAntigens, CD34Autoimmune DiseasesCombined Modality TherapyCyclophosphamideDermatomyositisFeasibility StudiesFemaleGranulomatosis with PolyangiitisHematopoietic Stem Cell MobilizationHumansImmunomagnetic SeparationImmunosuppressive AgentsMaleMiddle AgedAntigens, CD34CyclophosphamideImmunosuppressive Agents

Identifiers

PMID16126798
PMCPMC1798095
OpenAlexW2159641284

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.