Evidence map›Paper›PMID 23272061›Full record

Trial reportPloS one2012

T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial.

Dimitrios Karussis, Hagai Shor, Julia Yachnin, Naama Lanxner, Merav Amiel, Keren Baruch, Yael Keren-Zur, Ofra Haviv, Massimo Filippi, Panayiota Petrou and 8 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01448252 (Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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.

NCT01448252 phase1 / phase2completednot on this map

Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis

TypeinterventionalSponsorHadassah Medical OrganizationRan2002 to 2009Enrolled30ConditionsMultiple SclerosisArmsmultiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides), T cell vaccination
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. A comprehensive review on the treatment approaches of multiple sclerosis: currently and in the future.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2019
    Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Neuroimmunotherapies Targeting T Cells: From Pathophysiology to Therapeutic Applications.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2016
    Review
  19. Article
  20. Emerging immunopharmacological targets in multiple sclerosis.Journal of the neurological sciences · 2015
    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

18 authors at 3 institutions in 2 countries.

Dimitrios KarussisDepartment of Neurology, MS Center and the Agnes-Ginges Center for Neurogenetics, Hadassah-Hebrew University Hospital, Jerusalem, Israel. karus@cc.huji.ac.il
Hagai Shor
Julia Yachnin
Naama Lanxner
Merav Amiel
Keren Baruch
Yael Keren-Zur
Ofra Haviv
Massimo Filippi
Panayiota Petrou
Shalom Hajag
Urania Vourka-Karussis
Adi Vaknin-Dembinsky
Salim Khoury
Oded Abramsky
Henri Atlan
Irun R Cohen
Rivka Abulafia-Lapid
Hebrew University of Jerusalem · ILVita-Salute San Raffaele University · ITWeizmann Institute of Science · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundT-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled.

aimTo evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. METHODOLOGY: Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6) T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis.

resultsAt one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly.

conclusionsThis is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted.

trial registrationClinicalTrials.gov NCT01448252.

Indexed as

AdultDisease-Free SurvivalDouble-Blind MethodFemaleHumansLymphocytesMaleMultiple Sclerosis, Chronic ProgressiveMyelin SheathPeptidesPhenotypePlacebosRecurrenceTime FactorsT-LymphocytesVaccinationPeptidesPlacebos

Identifiers

PMID23272061
PMCPMC3522721
OpenAlexW1999690779

What OpenQuestion holds

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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.