Evidence map›Paper›PMID 27497700›Full record

ArticleCytotherapy2016

A robust, good manufacturing practice-compliant, clinical-scale procedure to generate regulatory T cells from patients with amyotrophic lateral sclerosis for adoptive cell therapy.

Abdullah Alsuliman, Stanley H Appel, David R Beers, Rafet Basar, Hila Shaim, Indresh Kaur, Jane Zulovich, Eric Yvon, Muharrem Muftuoglu, Nobuhiko Imahashi and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Cytotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04055623 (Phase 2a Study of the Expansion and Infusion of Autologous T-Regulatory Cells in Amyotrophic Lateral Sclerosis), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT04055623 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

Phase 2a Study of the Expansion and Infusion of Autologous T-Regulatory Cells in Amyotrophic Lateral Sclerosis

TypeinterventionalSponsorThe Methodist Hospital Research InstituteRan2019 to 2022Enrolled12ConditionsALS (Amyotrophic Lateral Sclerosis)ArmsMonthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections, Monthly placebo infusions + 3 times per week placebo injections
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 53 citations in OpenAlex.

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  15. Extracellular Vesicles Derived FromFrontiers in immunology · 2022
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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

14 authors at 2 institutions in 2 countries.

Abdullah AlsulimanStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA; Stem Cell & Tissue Re-engineering Program, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Stanley H AppelPeggy and Gary Edwards ALS Laboratory, Department of Neurology, Houston Methodist Neurological Institute, Houston Methodist Research Institute, Houston Methodist Hospital, Houston, Texas, USA.
David R BeersPeggy and Gary Edwards ALS Laboratory, Department of Neurology, Houston Methodist Neurological Institute, Houston Methodist Research Institute, Houston Methodist Hospital, Houston, Texas, USA.
Rafet BasarStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Hila ShaimStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Indresh KaurStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Jane ZulovichStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Eric YvonStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Muharrem MuftuogluStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Nobuhiko ImahashiStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Kayo KondoStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Enli LiuStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Elizabeth J ShpallStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
Katayoun RezvaniStem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: KRezvani@mdanderson.org.
The University of Texas MD Anderson Cancer Center · USHouston Methodist · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Regulatory T cells (Tregs) play a fundamental role in the maintenance of self-tolerance and immune homeostasis. Defects in Treg function and/or frequencies have been reported in multiple disease models. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder affecting upper and lower motor neurons. Compelling evidence supports a neuroprotective role for Tregs in this disease. Indeed, rapid progression in ALS patients is associated with decreased FoxP3 expression and Treg frequencies. Thus, we propose that strategies to restore Treg number and function may slow disease progression in ALS. In this study, we developed a robust, Good Manufacturing Practice (GMP)-compliant procedure to enrich and expand Tregs from ALS patients. Tregs isolated from these patients were phenotypically similar to those from healthy individuals but were impaired in their ability to suppress T-cell effector function. In vitro expansion of Tregs for 4 weeks in the presence of GMP-grade anti-CD3/CD28 beads, interleukin (IL)-2 and rapamcyin resulted in a 25- to 200-fold increase in their number and restored their immunoregulatory activity. Collectively, our data facilitate and support the implementation of clinical trials of adoptive therapy with ex vivo expanded and highly suppressive Tregs in patients with ALS.

Indexed as

Cell SeparationPrimary Cell CultureAdoptive TransferAmyotrophic Lateral SclerosisCase-Control StudiesCell- and Tissue-Based TherapyCells, CulturedGuideline AdherenceHumansImmune ToleranceInterleukin-2T-Lymphocytes, RegulatoryInterleukin-2amyotrophic lateral sclerosisgood manufacturing practicerapamycinregulatory T cells

Identifiers

PMID27497700
PMCPMC13195638
OpenAlexW2485947744

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.