Evidence map›Paper›PMID 26844283›Full record

Trial reportEBioMedicine2015

Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial.

Elias Delgado, Marcos Perez-Basterrechea, Beatriz Suarez-Alvarez, Huimin Zhou, Eva Martinez Revuelta, Jose Maria Garcia-Gala, Silvia Perez, Maria Alvarez-Viejo, Edelmiro Menendez, Carlos Lopez-Larrea and 7 more

4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in EBioMedicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT01350219 phase2unknown statusnot on this map

Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes

TypeinterventionalSponsorThrone Biotechnologies Inc.Ran2010 to 2019Enrolled100ConditionsType 1 DiabetesArmsStem Cell Educator
NCT03390231 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Molecular Mechanisms Underlying Stem Cell Educator Therapy for the Treatment of Diabetes

TypeinterventionalSponsorThrone Biotechnologies Inc.Ran2017 to 2020Enrolled100ConditionsDiabetes Mellitus, Type 1, Diabetes Mellitus, Type 2ArmsStem Cell Educator therapy
NCT04011020 phase2 / phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

TypeinterventionalSponsorThrone Biotechnologies Inc.Ran2022 to 2025Enrolled50ConditionsType 1 DiabetesArmsStem Cell Educator therapy
NCT04299152 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

TypeinterventionalSponsorThrone Biotechnologies Inc.Ran2021 to 2022Enrolled20ConditionsSevere Acute Respiratory Syndrome (SARS) PneumoniaArmsStem Cell Educator-Treated Mononuclear Cells Apheresis
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Cell Therapy for Type 1 Diabetes Mellitus: a Review of Clinical Trials.Bulletin of experimental biology and medicine · 2025
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Therapeutic Advances in Diabetes, Autoimmune, and Neurological Diseases.International journal of molecular sciences · 2021
    Review
  16. C-peptide and residual β-cell function in pediatric diabetes - state of the art.Pediatric endocrinology, diabetes, and metabolism · 2021
    Review
  17. Review
  18. Article
  19. Immune Modulation of Platelet-Derived Mitochondria on Memory CD4International journal of molecular sciences · 2020
    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

17 authors at 6 institutions in 3 countries.

Elias DelgadoEndocrinology Section, Department of Medicine, University de Oviedo, Oviedo 33006, Spain; Endocrinology and Nutrition Service, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Marcos Perez-BasterrecheaUnit of Transplants, Cell Therapy and Regenerative Medicine, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Beatriz Suarez-AlvarezCellular Biology of Renal Diseases Laboratory, Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid 28049, Spain.
Huimin ZhouSection of Endocrinology, The First Hospital of Hebei Medical University, Shijiazhuang 050031, PR China.
Eva Martinez RevueltaHematology and Hemotherapy Service, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Jose Maria Garcia-GalaHematology and Hemotherapy Service, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Silvia PerezUnit of Transplants, Cell Therapy and Regenerative Medicine, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Maria Alvarez-ViejoUnit of Transplants, Cell Therapy and Regenerative Medicine, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Edelmiro MenendezEndocrinology Section, Department of Medicine, University de Oviedo, Oviedo 33006, Spain; Endocrinology and Nutrition Service, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Carlos Lopez-LarreaDepartment of Immunology, Hospital Universitario Central de Asturias, Oviedo 33011, Spain; Fundación Renal "Iñigo Álvarez de Toledo", Madrid 28003, Spain.
Ruifeng TangDepartment of Hepatobiliary Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, PR China.
Zhenlong ZhuDepartment of Pathology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, PR China.
Wei HuDepartment of Research, Hackensack University Medical Center, Hackensack, NJ 07601, USA.
Thomas MossCORD:USE Cord Blood Bank, Orlando, FL 32810, USA.
Edward GuindiCORD:USE Cord Blood Bank, Orlando, FL 32810, USA.
Jesus OteroUnit of Transplants, Cell Therapy and Regenerative Medicine, Hospital Universitario Central de Asturias, Oviedo 33011, Spain.
Yong ZhaoDepartment of Research, Hackensack University Medical Center, Hackensack, NJ 07601, USA.
Hospital Universitario Central de Asturias · ESHackensack University Medical Center · USHebei Medical University · CNUniversidad de Oviedo · ESFourth Hospital of Hebei Medical University · CNHospital Universitario Fundación Jiménez Díaz · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundType 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet β cells. The complexities of overcoming autoimmunity in T1D have contributed to the challenges the research community faces when devising successful treatments with conventional immune therapies. Overcoming autoimmune T cell memory represents one of the key hurdles.

methodsIn this open-label, phase 1/phase 2 study, Caucasian T1D patients (N = 15) received two treatments with the Stem Cell Educator (SCE) therapy, an approach that uses human multipotent cord blood-derived multipotent stem cells (CB-SCs). SCE therapy involves a closed-loop system that briefly treats the patient's lymphocytes with CB-SCs in vitro and returns the "educated" lymphocytes (but not the CB-SCs) into the patient's blood circulation. This study is registered with ClinicalTrials.gov, NCT01350219.

findingsClinical data demonstrated that SCE therapy was well tolerated in all subjects. The percentage of naïve CD4(+) T cells was significantly increased at 26 weeks and maintained through the final follow-up at 56 weeks. The percentage of CD4(+) central memory T cells (TCM) was markedly and constantly increased at 18 weeks. Both CD4(+) effector memory T cells (TEM) and CD8(+) TEM cells were considerably decreased at 18 weeks and 26 weeks respectively. Additional clinical data demonstrated the modulation of C-C chemokine receptor 7 (CCR7) expressions on naïve T, TCM, and TEM cells. Following two treatments with SCE therapy, islet β-cell function was improved and maintained in individuals with residual β-cell function, but not in those without residual β-cell function.

interpretationCurrent clinical data demonstrated the safety and efficacy of SCE therapy in immune modulation. SCE therapy provides lasting reversal of autoimmune memory that could improve islet β-cell function in Caucasian subjects.

fundingObra Social "La Caixa", Instituto de Salud Carlos III, Red de Investigación Renal, European Union FEDER Funds, Principado de Asturias, FICYT, and Hackensack University Medical Center Foundation.

Indexed as

AutoimmunityImmunologic MemoryImmunomodulationStem Cell TransplantationAdultC-PeptideDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGene ExpressionHumansInsulin-Secreting CellsIslets of LangerhansMaleMiddle AgedReceptors, CCR7C-PeptideReceptors, CCR7AIRE, autoimmune regulatorAutoimmunityCB-SCs, human cord blood-derived multipotent stem cellsCCR7, C–C chemokine receptor 7Cord blood stem cellHbA1C, glycated hemoglobinHLA, human leukocyte antigenIL, interleukinImmune modulationM2, muscarinic acetylcholine receptor 2Memory T cellsMLR, mixed leukocyte reactionsMNC, mononuclear cellsOGTT, oral glucose tolerance testPBMC, peripheral blood mononuclear cellsR, responderSCE, Stem Cell EducatorS, stimulatorT1D, type 1 diabetesTCM, central memory T cellsTCR, T-cell receptorTEM, effector memory T cellsTGF-β1, transforming growth factor-β1Th, helper T cellTregs, regulatory T cellsType 1 diabetes

Identifiers

PMID26844283
PMCPMC4703710
OpenAlexW1942090571

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.