Clinical Manufacturing of Regulatory T Cell Products For Adoptive Cell Therapy and Strategies to Improve Therapeutic Efficacy

Regulatory T cells: A review of manufacturing and clinical utility

(2022) Tewodros Mamo et al.   TRANSFUSION

Utilization of Treg Cells in Solid Organ Transplantation

(2022) Tanya Juneja et al.   Frontiers in Immunology

A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy

(2022) Esther Bernaldo-de-Quirós et al.   Frontiers in Immunology

A phase 1 study of donor regulatory T-cell infusion plus low-dose interleukin-2 for steroid-refractory chronic graft-vs-host disease

(2022) Jennifer Whangbo et al.   Blood Advances

Low dose interleukin-2 selectively expands circulating regulatory T cells but fails to promote transplantation tolerance in humans

(2022) Tiong Yeng Lim et al.   JOURNAL OF HEPATOLOGY

Selective decrease of donor-reactive T regs after liver transplantation limits T reg therapy for promoting allograft tolerance in humans

(2022) Qizhi Tang et al.   Science Translational Medicine

First-in-human phase 1 trial of induced regulatory T cells for graft-versus-host disease prophylaxis in HLA-matched siblings

(2021) Margaret L. MacMillan et al.   Blood Advances

Selective expansion of regulatory T cells using an orthogonal IL-2/IL-2 receptor system facilitates transplantation tolerance

(2021) Toshihito Hirai et al.   JOURNAL OF CLINICAL INVESTIGATION

A Comparison of Ex Vivo Expanded Human Regulatory T Cells Using Allogeneic Stimulated B Cells or Monocyte-Derived Dendritic Cells

(2021) Linda M. Lee et al.   Frontiers in Immunology

The effect of low-dose IL-2 and Treg adoptive cell therapy in patients with type 1 diabetes

(2021) Shen Dong et al.   JCI Insight

Carbon-Based Materials in Photodynamic and Photothermal Therapies Applied to Tumor Destruction

(2021) Karina J. Lagos et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Regulatory T Cells and Human Disease

(2020) Shimon Sakaguchi et al.   Annual Review of Immunology

Engineered IL-2 Cytokine-Cytokine Receptor Complex Enables Selective Expansion of Regulatory T Cells and Facilitates Establishment of Organ Transplantation Tolerance

(2020) Toshihito Hirai et al.   BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION

A Clinical Trial with Adoptive Transfer of Ex Vivo-induced, Donor-specific Immune-regulatory Cells in Kidney Transplantation—A Second Report

(2020) Ichiro Koyama et al.   TRANSPLANTATION

Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials

(2020) Birgit Sawitzki et al.   LANCET

In situ recruitment of regulatory T cells promotes donor-specific tolerance in vascularized composite allotransplantation

(2020) James D. Fisher et al.   Science Advances

The Next Frontier of Regulatory T Cells: Promising Immunotherapy for Autoimmune Diseases and Organ Transplantations

(2020) Lauren V. Terry et al.   Frontiers in Immunology

Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy

(2020) Veerle Ide et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Methods to manufacture regulatory T cells for cell therapy

(2019) Katherine N. MacDonald et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Therapeutic use of regulatory T cells for graft‐versus‐host disease

(2019) Shlomo Elias et al.   BRITISH JOURNAL OF HAEMATOLOGY

Applicability, Safety And Biological Activity Of Regulatory T Cell Therapy In Liver Transplantation

(2019) Alberto Sánchez‐Fueyo et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Tolerance induction in HLA disparate living donor kidney transplantation by facilitating cell-enriched donor stem cell Infusion: The importance of durable chimerism

(2018) Joseph R. Leventhal et al.   HUMAN IMMUNOLOGY

Long-term follow-up of IPEX syndrome patients after different therapeutic strategies: An international multicenter retrospective study

(2018) Federica Barzaghi et al.   JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Selective targeting of engineered T cells using orthogonal IL-2 cytokine-receptor complexes

(2018) Jonathan T. Sockolosky et al.   SCIENCE

A Phase I Clinical Trial with Ex Vivo Expanded Recipient Regulatory T cells in Living Donor Kidney Transplants

(2018) James M. Mathew et al.   Scientific Reports

Cell Therapy in Organ Transplantation: Our Experience on the Clinical Translation of Regulatory T Cells

(2018) Niloufar Safinia et al.   Frontiers in Immunology

Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization

(2018) Anke Fuchs et al.   Frontiers in Immunology

A Rapamycin-Based GMP-Compatible Process for the Isolation and Expansion of Regulatory T Cells for Clinical Trials

(2018) Henrieta Fraser et al.   Molecular Therapy-Methods & Clinical Development

Ex vivo generation of umbilical cord blood T regulatory cells expressing the homing markers CD62L and cutaneous lymphocyte antigen

(2018) Joshua N. Kellner et al.   Oncotarget

Generation and Characterization of Alloantigen-Specific Regulatory T Cells For Clinical Transplant Tolerance

(2018) James M. Mathew et al.   Scientific Reports

mTOR Inhibitor Everolimus in Regulatory T cell Expansion for Clinical Application in Transplantation

(2018) Roberto Gedaly et al.   TRANSPLANTATION

Characterization and Expansion of Autologous GMP-ready Regulatory T Cells for TREG-based Cell Therapy in Patients with Ulcerative Colitis

(2017) Caroline J. Voskens et al.   INFLAMMATORY BOWEL DISEASES

Transplant trials with Tregs: perils and promises

(2017) Qizhi Tang et al.   JOURNAL OF CLINICAL INVESTIGATION

Treg therapy in transplantation: a general overview

(2017) Marco Romano et al.   TRANSPLANT INTERNATIONAL

Good Manufacturing Practice-Compliant Production and Lot-Release of Ex Vivo Expanded Regulatory T Cells As Basis for Treatment of Patients with Autoimmune and Inflammatory Disorders

(2017) Manuel Wiesinger et al.   Frontiers in Immunology

Single CD28 stimulation induces stable and polyclonal expansion of human regulatory T cells

(2017) Xuehui He et al.   Scientific Reports

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

(2016) Abdullah Alsuliman et al.   CYTOTHERAPY

A pilot study of operational tolerance with a regulatory T-cell-based cell therapy in living donor liver transplantation

(2016) Satoru Todo et al.   HEPATOLOGY

An essential role for the IL-2 receptor in Treg cell function

(2016) Takatoshi Chinen et al.   NATURE IMMUNOLOGY

Utilization of leukapheresis and CD4 positive selection in Treg isolation and the ex-vivo expansion for a clinical application in transplantation and autoimmune disorders

(2016) Karolina Gołąb et al.   Oncotarget

Successful expansion of functional and stable regulatory T cells for immunotherapy in liver transplantation

(2016) Niloufar Safinia et al.   Oncotarget

Discarded Human Thymus Is a Novel Source of Stable and Long-Lived Therapeutic Regulatory T Cells

(2015) I. E. Dijke et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Umbilical cord blood-derived T regulatory cells to prevent GVHD: kinetics, toxicity profile, and clinical effect

(2015) C. G. Brunstein et al.   BLOOD

Adoptive transfer of allogeneic regulatory T cells into patients with chronic graft-versus-host disease

(2015) Anke Theil et al.   CYTOTHERAPY

Developing in vitro expanded CD45RA+regulatory T cells as an adoptive cell therapy for Crohn's disease

(2015) James B Canavan et al.   GUT

Regulatory T Cells Require TCR Signaling for Their Suppressive Function

(2015) Amanda M. Schmidt et al.   JOURNAL OF IMMUNOLOGY

Type 1 diabetes immunotherapy using polyclonal regulatory T cells

(2015) Jeffrey A. Bluestone et al.   Science Translational Medicine

Regulatory T Cells: Serious Contenders in the Promise for Immunological Tolerance in Transplantation

(2015) Niloufar Safinia et al.   Frontiers in Immunology

Ex vivo fucosylation of third-party human regulatory T cells enhances anti-graft-versus-host disease potency in vivo

(2014) S. Parmar et al.   BLOOD

Ultra Low-Dose IL-2 for GVHD Prophylaxis after Allogeneic Hematopoietic Stem Cell Transplantation Mediates Expansion of Regulatory T Cells without Diminishing Antiviral and Antileukemic Activity

(2014) A. A. Kennedy-Nasser et al.   CLINICAL CANCER RESEARCH

Continuous T Cell Receptor Signals Maintain a Functional Regulatory T Cell Pool

(2014) J. Christoph Vahl et al.   IMMUNITY

CD28 Costimulation Is Essential for Human T Regulatory Expansion and Function

(2014) T. N. Golovina et al.   JOURNAL OF IMMUNOLOGY

Continuous requirement for the TCR in regulatory T cell function

(2014) Andrew G Levine et al.   NATURE IMMUNOLOGY

Ex Vivo Expanded Human Regulatory T Cells Delay Islet Allograft Rejection via Inhibiting Islet-Derived Monocyte Chemoattractant Protein-1 Production in CD34+ Stem Cells-Reconstituted NOD-scid IL2rγnull Mice

(2014) Fang Xiao et al.   PLoS One

Clinical Grade Manufacturing of Human Alloantigen-Reactive Regulatory T Cells for Use in Transplantation

(2013) A. L. Putnam et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Regulatory T cells: recommendations to simplify the nomenclature

(2013) Abul K Abbas et al.   NATURE IMMUNOLOGY

Donor-specific Regulatory T Cells Generated on Donor B Cells Are Superior to CD4+CD25high Cells in Controlling Alloimmune Responses in Humanized Mice

(2013) F. Noyan et al.   TRANSPLANTATION PROCEEDINGS

Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial

(2013) Agnès Hartemann et al.   Lancet Diabetes & Endocrinology

Bioinspired Controlled Release of CCL22 Recruits Regulatory T Cells In Vivo

(2012) Siddharth Jhunjhunwala et al.   ADVANCED MATERIALS

Administration of CD4+CD25highCD127- Regulatory T Cells Preserves  -Cell Function in Type 1 Diabetes in Children

(2012) N. Marek-Trzonkowska et al.   DIABETES CARE

Controlled release formulations of IL-2, TGF-β1 and rapamycin for the induction of regulatory T cells

(2012) Siddharth Jhunjhunwala et al.   JOURNAL OF CONTROLLED RELEASE

Human Regulatory T Cells of G-CSF Mobilized Allogeneic Stem Cell Donors Qualify for Clinical Application

(2012) Sya N. Ukena et al.   PLoS One

Regulatory T cells expanded by rapamycin in vitro suppress colitis in an experimental mouse model

(2011) Haruei Ogino et al.   JOURNAL OF GASTROENTEROLOGY

Interleukin-2 and Regulatory T Cells in Graft-versus-Host Disease

(2011) John Koreth et al.   NEW ENGLAND JOURNAL OF MEDICINE

Massive ex Vivo Expansion of Human Natural Regulatory T Cells (Tregs) with Minimal Loss of in Vivo Functional Activity

(2011) K. L. Hippen et al.   Science Translational Medicine

Human Regulatory T Cells with Alloantigen Specificity Are More Potent Inhibitors of Alloimmune Skin Graft Damage than Polyclonal Regulatory T Cells

(2011) P. Sagoo et al.   Science Translational Medicine

Long-Term Follow-Up of Recipients of Combined Human Leukocyte Antigen-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With End-Stage Renal Disease

(2011) Thomas R. Spitzer et al.   TRANSPLANTATION

Ex Vivo-Expanded Natural CD4+CD25+ Regulatory T Cells Synergize With Host T-Cell Depletion to Promote Long-Term Survival of Allografts

(2010) G. Xia et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics

(2010) C. G. Brunstein et al.   BLOOD

Adoptive transfer of CD4+CD25+ regulatory cells combined with low-dose sirolimus and anti-thymocyte globulin delays acute rejection of renal allografts in Cynomolgus monkeys

(2010) Anlun Ma et al.   INTERNATIONAL IMMUNOPHARMACOLOGY

In vivo prevention of transplant arteriosclerosis by ex vivo–expanded human regulatory T cells

(2010) Satish N Nadig et al.   NATURE MEDICINE

Ex Vivo–Expanded Human Regulatory T Cells Prevent the Rejection of Skin Allografts in a Humanized Mouse Model

(2010) Fadi Issa et al.   TRANSPLANTATION

Rapamycin Promotes the Expansion of CD4+ Foxp3+ Regulatory T Cells After Liver Transplantation

(2010) L. Lu et al.   TRANSPLANTATION PROCEEDINGS

First-in-man clinical results of the treatment of patients with graft versus host disease with human ex vivo expanded CD4+CD25+CD127− T regulatory cells

(2009) Piotr Trzonkowski et al.   CLINICAL IMMUNOLOGY

Mammalian Target of Rapamycin Inhibition and Alloantigen-Specific Regulatory T Cells Synergize To Promote Long-Term Graft Survival in Immunocompetent Recipients

(2009) G. Raimondi et al.   JOURNAL OF IMMUNOLOGY

Impact of the TCR Signal on Regulatory T Cell Homeostasis, Function, and Trafficking

(2009) Joong Kyu Kim et al.   PLoS One

Regulatory T Cells and Immune Tolerance

(2008) Shimon Sakaguchi et al.   CELL

Conferring indirect allospecificity on CD4+CD25+ Tregs by TCR gene transfer favors transplantation tolerance in mice

(2008) Julia Yuen-Shan Tsang et al.   JOURNAL OF CLINICAL INVESTIGATION

Clinical Grade Treg: GMP Isolation, Improvement of Purity by CD127pos Depletion, Treg Expansion, and Treg Cryopreservation

(2008) Jorieke H. Peters et al.   PLoS One