Building blocks for institutional preparation of CTL019 delivery.

Abstract:

:Chimeric antigen receptor (CAR) T-cell therapy is an investigational immunocellular therapy that reprograms a patient's cytotoxic T cells to engage and eliminate malignant cells. CAR T-cell therapies targeting the CD19 antigen have demonstrated high efficacy in clinical trials for patients with B-cell malignancies and may potentially be available on a broader scale in the future. CAR T-cell therapy begins with the collection of a sufficient number of T cells from a patient's peripheral blood through leukapheresis. Several factors must be considered when patients undergo leukapheresis for CAR T-cell therapy, including age and prior therapies. The leukapheresis material is shipped to a manufacturing facility, followed by return of the CAR T cells to the treatment center. Careful coordination of a multidisciplinary team composed of physicians, nurses, pharmacists and other hospital personnel is critical for the proper care of the patient before, during and after CAR T-cell therapy. CAR T-cell therapy has been associated with adverse events (AEs) such as cytokine release syndrome, which requires rapid attention by the emergency department, intensive care unit and hospital pharmacy. In this review, we discuss several aspects of institutional preparation for leukapheresis, CAR T-cell infusion and AE management based on our experience with clinical trials of the CD19 CAR T-cell therapy CTL019.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

McGuirk J,Waller EK,Qayed M,Abhyankar S,Ericson S,Holman P,Keir C,Myers GD

doi

10.1016/j.jcyt.2017.06.001

subject

Has Abstract

pub_date

2017-09-01 00:00:00

pages

1015-1024

issue

9

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(17)30600-X

journal_volume

19

pub_type

杂志文章,评审
  • CD4(+) CD25(+) regulatory T cells ameliorate Behcet's disease-like symptoms in a mouse model.

    abstract:BACKGROUND AIMS:Behcet's disease (BD) is a chronic, multisystemic inflammatory disorder with arthritic, gastrointestinal, mucocutaneous, ocular, vascular and central nervous system involvement. It is well known that CD4(+) CD25(+) T-regulatory (Treg) cells prevent harmful immune responses to self- and non-self-antigens...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2011.571245

    authors: Shim J,Lee ES,Park S,Bang D,Sohn S

    更新日期:2011-08-01 00:00:00

  • Adipose-derived mesenchymal stromal cells from genetically modified pigs: immunogenicity and immune modulatory properties.

    abstract:BACKGROUND AIMS:The immunomodulatory and anti-inflammatory effects of mesenchymal stromal cells (MSC) could prove to be a potential therapeutic approach for prolongation of survival of cell xenotransplantation. Adipose (Ad) MSC from genetically modified pigs could be an abundant source of pig donor-specific MSC. METHO...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2011.651529

    authors: Kumar G,Hara H,Long C,Shaikh H,Ayares D,Cooper DK,Ezzelarab M

    更新日期:2012-04-01 00:00:00

  • Cryopreserved mesenchymal stromal cell treatment is safe and feasible for severe dilated ischemic cardiomyopathy.

    abstract:BACKGROUND AIMS:Bone marrow (BM) mesenchymal stromal cells (MSC) represent a novel therapy for severe heart failure with extensive myocardial scarring, especially when performed concurrently with conventional revascularization. However, stem cells are difficult to transport in culture media without risk of contaminatio...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653240903313966

    authors: Chin SP,Poey AC,Wong CY,Chang SK,Teh W,Mohr TJ,Cheong SK

    更新日期:2010-01-01 00:00:00

  • Impact of chronicity of injury on the proportion of mesenchymal stromal cells derived from anterior cruciate ligaments.

    abstract:BACKGROUND AIMS:The graft-healing potential of mesenchymal stromal cells (MSCs) derived from the remnants of ruptured anterior cruciate ligaments (ACLs) after ACL reconstruction may depend on the chronicity of the injury. The aim of this study was to assess the quantitative and phenotypic differences between MSCs isola...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.08.001

    authors: Lee DH,Ng J,Chung JW,Sonn CH,Lee KM,Han SB

    更新日期:2014-05-01 00:00:00

  • A strategy for single nucleotide polymorphism analysis of chimerism for somatic cell therapy.

    abstract:BACKGROUND AIMS:Chimerism is an important outcome measure in hematopoietic cell transplantation as well as somatic cell therapy. Commonly used methods to estimate chimerism are restricted by either gender or inefficient sensitivity. In principle, real-time polymerase chain reaction (PCR)-based assays can be used to ass...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653241003774029

    authors: Chen X,Hofmann TJ,Otsuru S,Jethva R,Lind C,Monos D,Horwitz EM

    更新日期:2010-12-01 00:00:00

  • Adipose tissue-derived mesenchymal stem cell yield and growth characteristics are affected by the tissue-harvesting procedure.

    abstract:BACKGROUND:Adipose tissue contains a stromal vascular fraction that can be easily isolated and provides a rich source of adipose tissue-derived mesenchymal stem cells (ASC). These ASC are a potential source of cells for tissue engineering. We studied whether the yield and growth characteristics of ASC were affected by ...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240600621125

    authors: Oedayrajsingh-Varma MJ,van Ham SM,Knippenberg M,Helder MN,Klein-Nulend J,Schouten TE,Ritt MJ,van Milligen FJ

    更新日期:2006-01-01 00:00:00

  • Safety and efficacy of granulocyte-colony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia.

    abstract:BACKGROUND AIMS:The aim was to investigate the therapeutic effect of granulocyte-colony-stimulating factor (G-CSF) administration following implantation of autologous bone marrow mononuclear cells (BM MNC) for patients with lower limb ischemia. METHODS:The design was a randomized controlled trial. Fifteen patients wit...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.3109/14653240903518163

    authors: Zafarghandi MR,Ravari H,Aghdami N,Namiri M,Moazzami K,Taghiabadi E,Fazel A,Pournasr B,Farrokhi A,Sharifian RA,Salimi J,Moini M,Baharvand H

    更新日期:2010-10-01 00:00:00

  • T lymphocytes engineered to express a CD16-chimeric antigen receptor redirect T-cell immune responses against immunoglobulin G-opsonized target cells.

    abstract:BACKGROUND AIMS:Chimeric antigen receptors (CARs) designed for adoptive immunotherapy need to achieve two functions: antigen recognition and triggering of the lytic machinery of reprogrammed effector cells. Cytotoxic T cells have been engineered with FcγRIII (CD16) chimeric molecules to be redirected against malignant ...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.10.014

    authors: D'Aloia MM,Caratelli S,Palumbo C,Battella S,Arriga R,Lauro D,Palmieri G,Sconocchia G,Alimandi M

    更新日期:2016-02-01 00:00:00

  • Natural killer cell-based immunotherapeutic strategies.

    abstract::Not until recently have Natural killer (NK) cells stepped out of the shadow of T-cells to be considered for cellular therapy of malignant diseases. This evolution has been facilitated by the discovery of specific receptors on NK cells that interact with HLA molecules on target cells but also the discovery of specific ...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1080/14653240510018000

    authors: Klingemann HG

    更新日期:2005-01-01 00:00:00

  • Adipose mesenchymal stromal cells minimize and repair radiation-induced oral mucositis.

    abstract:BACKGROUND AIMS:Mesenchymal stromal cells (MSCs) have been used to minimize and repair radiation-induced normal tissue injury in the intestine, salivary gland, liver, skin, lungs and cardiac muscle. This study investigated the ability of adipose tissue-derived MSCs (aMSCs) to minimize and/or repair single dose radiatio...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.06.008

    authors: Maria OM,Shalaby M,Syme A,Eliopoulos N,Muanza T

    更新日期:2016-09-01 00:00:00

  • Yield and proliferation rate of adipose-derived stromal cells as a function of age, body mass index and harvest site-increasing the yield by use of adherent and supernatant fractions?

    abstract:BACKGROUND AIMS:Adipose-derived stem cells are easily accessed and have a relatively high density compared with other mesenchymal stromal cells. Isolation protocols of adipose-derived stem cells (ASC) rely on the cell's ability to adhere to tissue culture plastic overnight. It was evaluated whether the floating ASC fra...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.04.009

    authors: Buschmann J,Gao S,Härter L,Hemmi S,Welti M,Werner CM,Calcagni M,Cinelli P,Wanner GA

    更新日期:2013-09-01 00:00:00

  • Transplantation of embryonic stem cell-derived cardiomyocytes improves cardiac function in infarcted rat hearts.

    abstract:BACKGROUND:Post-infarct congestive heart failure is one of the leading causes of morbidity and mortality in industrialized countries. The main purpose of this study was to investigate whether transplantation of embryonic stem cell-derived cardiomyocytes (ESCM) directly into the infarcted myocardium could improve cardia...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240701247838

    authors: Cai J,Yi FF,Yang XC,Lin GS,Jiang H,Wang T,Xia Z

    更新日期:2007-01-01 00:00:00

  • Current evidence on mesenchymal stem cell therapy for traumatic spinal cord injury: systematic review and meta-analysis.

    abstract:BACKGROUND AIMS:The authors aim to analyze the evidence in the literature regarding the efficacy and safety of mesenchymal stem cell (MSC) therapy in human subjects with traumatic spinal cord injury (SCI) and identify its potential role in the management of SCI. METHODS:The authors conducted independent and duplicate ...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1016/j.jcyt.2020.09.007

    authors: Muthu S,Jeyaraman M,Gulati A,Arora A

    更新日期:2020-11-09 00:00:00

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

    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 neur...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.06.012

    authors: Alsuliman A,Appel SH,Beers DR,Basar R,Shaim H,Kaur I,Zulovich J,Yvon E,Muftuoglu M,Imahashi N,Kondo K,Liu E,Shpall EJ,Rezvani K

    更新日期:2016-10-01 00:00:00

  • International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials.

    abstract::Mesenchymal stromal cells (MSCs) as a pharmaceutical for ailments characterized by pathogenic autoimmune, alloimmune and inflammatory processes now cover the spectrum of early- to late-phase clinical trials in both industry and academic sponsored studies. There is a broad consensus that despite different tissue sourci...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.11.008

    authors: Galipeau J,Krampera M,Barrett J,Dazzi F,Deans RJ,DeBruijn J,Dominici M,Fibbe WE,Gee AP,Gimble JM,Hematti P,Koh MB,LeBlanc K,Martin I,McNiece IK,Mendicino M,Oh S,Ortiz L,Phinney DG,Planat V,Shi Y,Stroncek DF,Vi

    更新日期:2016-02-01 00:00:00

  • Mesenchymal stem cells: immunobiology and role in immunomodulation and tissue regeneration.

    abstract::Mesenchymal stem cells (MSC) are multipotent cells that differentiate into osteoblasts, myocytes, chondrocytes and adipocytes as well as insulin-producing cells. The mechanism underlying their in vivo differentiation is not clear and is thought to be caused by spontaneous cell fusion or factors present in the microenv...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1080/14653240903080367

    authors: Kode JA,Mukherjee S,Joglekar MV,Hardikar AA

    更新日期:2009-01-01 00:00:00

  • In vitro cardiomyocyte differentiation of umbilical cord blood cells: crucial role for c-kit(+) cells.

    abstract:BACKGROUND AIMS:Although bone marrow c-kit(+) progenitor cells support myocardial regeneration, the cardiomyocyte differentiation potential of umbilical cord blood (UCB) c-kit(+) cells is unknown. METHODS:UCB mononuclear cells (MNCs) and c-kit(+) cells purified by use of immunomagnetic beads were used. Cardiomyocyte d...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.07.012

    authors: Iachininoto MG,Capodimonti S,Podda MV,Valentini CG,Bianchi M,Leone AM,Teofili L,Leone G

    更新日期:2015-11-01 00:00:00

  • Bovine dialyzable leukocyte extract modulates AP-1 DNA-binding activity and nuclear transcription factor expression in MCF-7 breast cancer cells.

    abstract:BACKGROUND:We have previously demonstrated that bovine dialyzable leukocyte extract (bDLE) induces death through an apoptosis mechanism in MCF-7 breast cancer cells. Depending on the cell type and stimulus, activating protein-1 (AP-1) has been shown to regulate cell proliferation and differentiation, the stress respons...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240801891659

    authors: Mendoza-Gamboa E,Franco-Molina MA,Zapata-Benavides P,Castillo-Tello P,Vera-García ME,Tamez-Guerra RS,Rodríguez-Padilla C

    更新日期:2008-01-01 00:00:00

  • Bone marrow mesenchymal stromal cells ameliorate angiogenesis and renal damage via promoting PI3k-Akt signaling pathway activation in vivo.

    abstract:OBJECTIVE:The objective of this study was to investigate the effects of the intravenous transplantation of bone marrow mesenchymal stromal cells (BM-MSCs) on the repair of glomerular endothelia and angiogenesis in rats with chronic renal failure (CRF). Furthermore, the mechanism of BM-MSCs promoting angiogenesis was ex...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.03.300

    authors: Jia X,Pan J,Li X,Li N,Han Y,Feng X,Cui J

    更新日期:2016-07-01 00:00:00

  • Clinical analysis of the treatment of spinal cord injury with umbilical cord mesenchymal stem cells.

    abstract:BACKGROUND AIMS:The purpose of this study was to observe the clinical effect and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in treating spinal cord injury (SCI) by intrathecal injection. METHODS:From January 2008 to October 2010, we treated 22 patients with SCI with UC-MSCs by intrathecal injection; dos...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2012.09.005

    authors: Liu J,Han D,Wang Z,Xue M,Zhu L,Yan H,Zheng X,Guo Z,Wang H

    更新日期:2013-02-01 00:00:00

  • Dendritic cell-activated cytokine-induced killer cells enhance the anti-tumor effect of chemotherapy on non-small cell lung cancer in patients after surgery.

    abstract:BACKGROUND AIMS:Cytokine-induced killer (CIK) cells have shown cytolytic activity against several tumor cells in vitro and in animal tumor models. Furthermore, CIK cells activated by dendritic cell (DC) stimulation show increased anti-tumor activity. This study aimed to evaluate the clinical efficacy of DC-activated CI...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章

    doi:10.3109/14653240903121252

    authors: Li H,Wang C,Yu J,Cao S,Wei F,Zhang W,Han Y,Ren XB

    更新日期:2009-01-01 00:00:00

  • BM-derived cells restore expression of peroxiredoxin V in the airways following acute naphthalene injury in mice.

    abstract:BACKGROUND:Naphthalene-induced respiratory tract toxicity in mice is characterized by specific and rapid loss of the Clara cell population, which is restored only after several days. The sources of restoration of this cell population remain unclear. We investigated whether BM-derived cells participated in the process o...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240500361012

    authors: Serikov VB,Popov BV,Kropotov AV,Tomilin NV

    更新日期:2005-01-01 00:00:00

  • Immunological and clinical effects of post-transplant G-CSF versus placebo in T-cell replete allogeneic blood transplant patients: results from a randomized double-blind study.

    abstract:BACKGROUND:Immunological and clinical effects of post-transplant growth factor administration have not been well studied. This report describes the outcome and immune functions of a total of 50 HLA-matched related donor allogeneic blood stem-cell transplantation patients who received post-transplant G-CSF (10 microg/kg...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1080/14653240310003648

    authors: Joshi SS,Bishop MR,Lynch JC,Tarantolo SR,Abhyankar S,Bierman PJ,Vose JM,Geller RB,McGuirk J,Foran J,Bociek RG,Hadi A,Day SD,Armitage JO,Kessinger A,Pavletic ZS

    更新日期:2003-01-01 00:00:00

  • Stem cell comparison: what can we learn clinically from unrelated cord blood transplantation as an alternative stem cell source?

    abstract::Allogeneic hematopoietic cell transplantation (HCT) is an important therapeutic option for a variety of malignant and non-malignant disorders (NMD). The use of umbilical cord blood transplantation (UCBT) has made HCT available to many more patients. The increased level of human leukocyte antigen disparity that can be ...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1016/j.jcyt.2015.03.003

    authors: Milano F,Boelens JJ

    更新日期:2015-06-01 00:00:00

  • Long-term outcome of a phase II study of BM transplants, partially depleted ex-vivo of CD5-positive and CD8-positive T-lymphocytes in unrelated and related donor 1 antigen mismatched recipients.

    abstract:BACKGROUND:Mismatched family donor and unrelated donor BM transplants are associated with a high risk of acute GvHD. White T-cell depletion is the best method to reduce risk of acute GvHD, there was a reluctance to use T-cell depletion in the mismatched setting because of increased risk of rejection and relapse. Partia...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/0032472031000141284

    authors: Gajewski JL,Nimer S,Saliba RM,Thomas M,Przepiorka D,Giralt S,von Besien K,Mehra R,Andersson B,Chan KW,Ippoliti C,Warkinten D,Feigs S,Territo M,Schiller G,Lebkowski J,Moseley AM,Lloyd K,von Hoeff M,Okarma T,Champli

    更新日期:1999-01-01 00:00:00

  • Human mesenchymal stromal cells transiently increase cytokine production by activated T cells before suppressing T-cell proliferation: effect of interferon-γ and tumor necrosis factor-α stimulation.

    abstract:BACKGROUND AIMS:Mesenchymal stromal cells (MSCs) suppress T-cell proliferation, especially after activation with inflammatory cytokines. We compared the dynamic action of unprimed and interferon (IFN)-γ plus tumor necrosis factor (TNF)-α-pretreated human bone marrow-derived MSCs on resting or activated T cells. METHOD...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.11.008

    authors: Cuerquis J,Romieu-Mourez R,François M,Routy JP,Young YK,Zhao J,Eliopoulos N

    更新日期:2014-02-01 00:00:00

  • Implantation of BM mesenchymal stem cells into injured spinal cord elicits de novo neurogenesis and functional recovery: evidence from a study in rhesus monkeys.

    abstract:BACKGROUND:Transplantation of mesenchymal stem cells (MSC) in rodent models has proved to be an effective therapeutic approach for spinal cord injury (SCI). However, further studies in primate models are still needed before clinical application of MSC to patients. METHODS:MSC were isolated from rhesus monkey BM and in...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240600760808

    authors: Deng YB,Liu XG,Liu ZG,Liu XL,Liu Y,Zhou GQ

    更新日期:2006-01-01 00:00:00

  • Simplified process for the production of anti-CD19-CAR-engineered T cells.

    abstract:BACKGROUND AIMS:Adoptive immunotherapy with the use of chimeric antigen receptor (CAR)-engineered T cells specific for CD19 has shown promising results for the treatment of B-cell lymphomas and leukemia. This therapy involves the transduction of autologous T cells with a viral vector and the subsequent cell expansion. ...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.06.003

    authors: Tumaini B,Lee DW,Lin T,Castiello L,Stroncek DF,Mackall C,Wayne A,Sabatino M

    更新日期:2013-11-01 00:00:00

  • Induction of potent protection against acute and latent herpes simplex virus infection in mice vaccinated with dendritic cells.

    abstract:BACKGROUND AIMS:Dendritic cells (DCs) are the most potent antigen presenting cells of the immune system and have been under intense study with regard to their use in immunotherapy against cancer and infectious disease agents. In the present study, DCs were employed to assess their value in protection against live virus...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2012.11.012

    authors: Ghasemi M,Erturk M,Buruk K,Sonmez M

    更新日期:2013-03-01 00:00:00

  • Comparative analysis of the immunomodulatory capacities of human bone marrow- and adipose tissue-derived mesenchymal stromal cells from the same donor.

    abstract:BACKGROUND AIMS:The immunomodulatory properties of mesenchymal stromal cells (MSCs), together with their tissue regenerative potential, make them interesting candidates for clinical application. METHODS:In the current study, we analyzed the in vitro immunomodulatory effects of MSCs derived from bone marrow (BM-MSCs) a...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.07.006

    authors: Valencia J,Blanco B,Yáñez R,Vázquez M,Herrero Sánchez C,Fernández-García M,Rodríguez Serrano C,Pescador D,Blanco JF,Hernando-Rodríguez M,Sánchez-Guijo F,Lamana ML,Segovia JC,Vicente Á,Del Cañizo C,Zapata AG

    更新日期:2016-10-01 00:00:00