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  1. Article ; Online: Improving CAR T cell therapy by optimizing critical quality attributes.

    Reddy, Opal L / Stroncek, David F / Panch, Sandhya R

    Seminars in hematology

    2020  Volume 57, Issue 2, Page(s) 33–38

    Abstract: Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these ... ...

    Abstract Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these therapies are not effective for all patients, and are not without toxicities. The challenge now is to optimize these products and their manufacture. The manufacturing process is complex and subject to numerous variabilities at each step. These variabilities can affect the critical quality attributes of the final product, and this can ultimately impact clinical outcomes. This review will focus on optimizing the manufacturing variables that can impact the safety, purity, potency, consistency and durability of CAR-T cells.
    MeSH term(s) Hematologic Neoplasms/immunology ; Hematologic Neoplasms/therapy ; Humans ; Immunotherapy, Adoptive/methods ; Receptors, Antigen, T-Cell/therapeutic use
    Chemical Substances Receptors, Antigen, T-Cell
    Language English
    Publishing date 2020-07-27
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 206923-4
    ISSN 1532-8686 ; 0037-1963
    ISSN (online) 1532-8686
    ISSN 0037-1963
    DOI 10.1053/j.seminhematol.2020.07.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 328: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Advances in gene therapy for hematologic disease and considerations for transfusion medicine.

    Reddy, Opal L / Savani, Bipin N / Stroncek, David F / Panch, Sandhya R

    Seminars in hematology

    2020  Volume 57, Issue 2, Page(s) 83–91

    Abstract: As the list of regulatory agency-approved gene therapies grows, these products are now in the therapeutic spotlight with the potential to cure or dramatically alleviate several benign and malignant hematologic diseases. The mechanisms for gene ... ...

    Abstract As the list of regulatory agency-approved gene therapies grows, these products are now in the therapeutic spotlight with the potential to cure or dramatically alleviate several benign and malignant hematologic diseases. The mechanisms for gene manipulation are diverse, and include the use of a variety of cell sources and both viral vector- and nuclease-based targeted approaches. Gene editing has also reached the realm of blood component therapy and testing, where cultured products are being developed to improve transfusion support for individuals with rare blood types. In this review, we summarize the milestones in the development of gene therapies for hematologic diseases, mechanisms for gene manipulation, and implications for transfusion medicine and blood centers as these therapies continue to advance and grow.
    MeSH term(s) Genetic Therapy/methods ; Hematologic Diseases/genetics ; Hematologic Diseases/therapy ; Humans ; Transfusion Medicine/methods
    Language English
    Publishing date 2020-07-28
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 206923-4
    ISSN 1532-8686 ; 0037-1963
    ISSN (online) 1532-8686
    ISSN 0037-1963
    DOI 10.1053/j.seminhematol.2020.07.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 328: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Effects of extended transport on cryopreserved allogeneic hematopoietic progenitor cell (HPC) product quality and optimal methods to assess HPC stability.

    Reddy, Opal L / Sall, Mame Thioye / Dinh, Anh / Cai, Yihua / Ongkeko, Martin / Arya, Nina / Wilder, Jennifer / Tran, Minh / Jin, Ping / Stroncek, David F / Panch, Sandhya R

    Transfusion

    2023  Volume 63, Issue 4, Page(s) 774–781

    Abstract: Background: Since the beginning of the COVID-19 pandemic, cryopreservation of hematopoietic progenitor cell (HPC) products has been increasingly used to ensure allogeneic donor graft availability prior to recipient conditioning for transplantation. ... ...

    Abstract Background: Since the beginning of the COVID-19 pandemic, cryopreservation of hematopoietic progenitor cell (HPC) products has been increasingly used to ensure allogeneic donor graft availability prior to recipient conditioning for transplantation. However, in addition to variables such as graft transport duration and storage conditions, the cryopreservation process itself may adversely affect graft quality. Furthermore, the optimal methods to assess graft quality have not yet been determined.
    Study design and methods: A retrospective review was performed on all cryopreserved HPCs processed and thawed at our facility from 2007 to 2020, including both those collected onsite and by the National Marrow Donor Program (NMDP). HPC viability studies were also performed on fresh products, retention vials, and corresponding final thawed products by staining for 7-AAD (flow cytometry), AO/PI (Cellometer), and trypan blue (manual microscopy). Comparisons were made using the Mann-Whitney test.
    Results: For HPC products collected by apheresis (HPC(A)), pre-cryopreservation and post-thaw viabilities, as well as total nucleated cell recoveries were lower for products collected by the NMDP compared to those collected onsite. However, there were no differences seen in CD34+ cell recoveries. Greater variation in viability testing was observed using image-based assays compared to flow-based assays, and on cryo-thawed versus fresh samples. No significant differences were observed between viability measurements obtained on retention vials versus corresponding final thawed product bags.
    Discussion: Our studies suggest extended transport may contribute to lower post-thaw viabilities, but without affecting CD34+ cell recoveries. To assess HPC viability prior to thaw, testing of retention vials offers predictive utility, particularly when automated analyzers are used.
    MeSH term(s) Humans ; Hematopoietic Stem Cell Transplantation/methods ; Pandemics ; COVID-19 ; Hematopoietic Stem Cells ; Cryopreservation/methods ; Antigens, CD34 ; Cell Survival
    Chemical Substances Antigens, CD34
    Language English
    Publishing date 2023-03-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.17314
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 284: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: Programmed death-ligand 1 (PD-L1) is expressed in a significant number of the uterine cervical carcinomas.

    Reddy, Opal L / Shintaku, Peter I / Moatamed, Neda A

    Diagnostic pathology

    2017  Volume 12, Issue 1, Page(s) 45

    Abstract: Background: The programmed death-1/programmed death-ligand-1 (PD-1/PD-L1) immune regulatory axis has emerged as a promising new target for cancer therapeutics, with lasting responses seen in the treatment of metastatic renal and lung carcinomas, as well ...

    Abstract Background: The programmed death-1/programmed death-ligand-1 (PD-1/PD-L1) immune regulatory axis has emerged as a promising new target for cancer therapeutics, with lasting responses seen in the treatment of metastatic renal and lung carcinomas, as well as melanomas. As tumor surface expression of PD-L1 has been found to correlate with objective responses to anti-PD-L1 immunotherapies, we investigated the expression of PD-L1 in human cervical tumors and provide an adopted scoring system for the systematic evaluation of PD-L1 staining.
    Methods: Immunohistochemical staining for PD-L1 expression was performed on a tissue microarray of 101 normal and neoplastic cervical tissues. Neoplastic cores were divided into three groups: squamous cell carcinoma, adenosquamous carcinoma, and endocervical adenocarcinoma. PD-L1 expression was scored based on an adopted scoring system accounting to percentage and intensity of positivity, and results provided alongside available clinical and demographic data.
    Results: Overall, PD-L1 was positive in 32 of 93 (34.4%) cervical carcinomas. Subcategorically, PD-L1 was positive in 28 of 74 (37.8%) squamous cell carcinomas, two of seven (28.6%) adenosquamous carcinomas, and two of 12 (16.7%) endocervical adenocarcinomas. It was negative in six benign cervical tissues.
    Conclusions: This study shows a significant expression of PD-L1 in 34.4% of cervical carcinomas and no expression of PD-L1 in benign cervical tissues. These findings suggest a role for further investigation of anti-PD-L1/PD-1 immunotherapies in the treatment of PD-L1-positive cervical tumors. In addition, our adopted scoring system will facilitate more systematic correlations between tumor reactivity and response to treatment.
    MeSH term(s) Adenocarcinoma/pathology ; Adult ; Aged ; B7-H1 Antigen/metabolism ; Biomarkers, Tumor/metabolism ; Carcinoma, Squamous Cell/metabolism ; Carcinoma, Squamous Cell/pathology ; Female ; Humans ; Immunohistochemistry/methods ; Lung Neoplasms/pathology ; Middle Aged ; Tissue Array Analysis/methods ; Uterine Cervical Neoplasms/metabolism ; Uterine Cervical Neoplasms/pathology
    Chemical Substances B7-H1 Antigen ; Biomarkers, Tumor ; CD274 protein, human
    Language English
    Publishing date 2017-06-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 2210518-9
    ISSN 1746-1596 ; 1746-1596
    ISSN (online) 1746-1596
    ISSN 1746-1596
    DOI 10.1186/s13000-017-0631-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Application of Immunohistochemistry in the Diagnosis of Pulmonary and Pleural Neoplasms.

    Woo, Jennifer S / Reddy, Opal L / Koo, Matthew / Xiong, Yan / Li, Faqian / Xu, Haodong

    Archives of pathology & laboratory medicine

    2017  Volume 141, Issue 9, Page(s) 1195–1213

    Abstract: Context: - A vast majority of neoplasms arising from lung or pleura are initially diagnosed based on the histologic evaluation of small transbronchial, endobronchial, or needle core biopsies. Although most diagnoses can be determined by morphology alone, ...

    Abstract Context: - A vast majority of neoplasms arising from lung or pleura are initially diagnosed based on the histologic evaluation of small transbronchial, endobronchial, or needle core biopsies. Although most diagnoses can be determined by morphology alone, immunohistochemistry can be a valuable diagnostic tool in the workup of problematic cases.
    Objective: - To provide a practical approach in the interpretation and immunohistochemical selection of lung/pleura-based neoplasms obtained from small biopsy samples.
    Data sources: - A literature review of previously published articles and the personal experience of the authors were used in this review article.
    Conclusion: - Immunohistochemistry is a useful diagnostic tool in the workup of small biopsies from the lung and pleura sampled by small biopsy techniques.
    MeSH term(s) Aged ; Aged, 80 and over ; Female ; Humans ; Immunohistochemistry/methods ; Lung Neoplasms/diagnosis ; Male ; Pleural Neoplasms/diagnosis
    Language English
    Publishing date 2017-09
    Publishing country United States
    Document type Case Reports ; Journal Article ; Review
    ZDB-ID 194119-7
    ISSN 1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
    ISSN (online) 1543-2165
    ISSN 0363-0153 ; 0096-8528 ; 0003-9985
    DOI 10.5858/arpa.2016-0550-RA
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ud II Zs.36: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
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  6. Article ; Online: Robust Selections of Various Hematopoietic Cell Fractions on the CliniMACS Plus Instrument.

    Panch, Sandhya R / Reddy, Opal L / Li, Katherine / Bikkani, Thejaswi / Rao, Anusha / Yarlagadda, Swathi / Highfill, Steven / Fowler, Daniel / Childs, Richard W / Battiwalla, Minocher / Barrett, John / Larochelle, Andre / Mackall, Crystal / Shah, Nirali / Stroncek, David F

    Clinical hematology international

    2019  Volume 1, Issue 3, Page(s) 161–167

    Abstract: Cell separation technologies play a vital role in the graft engineering of hematopoietic cellular fractions, particularly with the rapid expansion of the field of cellular therapeutics. The CliniMACS Plus Instrument (Miltenyi Biotec) utilizes ... ...

    Abstract Cell separation technologies play a vital role in the graft engineering of hematopoietic cellular fractions, particularly with the rapid expansion of the field of cellular therapeutics. The CliniMACS Plus Instrument (Miltenyi Biotec) utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells (HPCs), T cells, NK cells, and monocytes. These products are ultimately used for HPC transplantation and for the manufacture of adoptive immunotherapies. We evaluated the viable cell recovery and cell purity of selections and depletions performed on the CliniMACS Plus over a 10-year period at our facility, specifically assessing for the isolation of CD34+, CD4+, CD3+/CD56+, CD4+/CD8+, and CD25+ cells. Additionally, patient- and instrument-related factors affecting these parameters were examined. Viable cell recovery ranged from 32.3 ± 10.2% to 65.4 ± 15.4%, and was the highest for CD34+ selections. Cell purity ranged from 86.3 ± 7.2% to 99.0 ± 1.1%, and was the highest for CD4+ selections. Undesired cell fractions demonstrated a range of 1.2 ± 0.45 to 5.1 ± 0.4 log reductions. Red cell depletions averaged 2.12 ± 0.68 logs, while platelets were reduced by an average of 4.01 ± 1.57 logs. Donor characteristics did not impact viable cell recovery or cell purity for CD34+ or CD4+ cell enrichments; however, these were affected by manufacturing variables, including tubing size, bead quantity, and whether preselection platelet washes were performed. Our data demonstrate the efficient recovery of hematopoietic cellular fractions on the CliniMACS Plus that may be optimized by adjusting manufacturing variables.
    Language English
    Publishing date 2019-09-01
    Publishing country France
    Document type Journal Article
    ISSN 2590-0048
    ISSN (online) 2590-0048
    DOI 10.2991/chi.d.190529.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Loss of FOXA1 Drives Sexually Dimorphic Changes in Urothelial Differentiation and Is an Independent Predictor of Poor Prognosis in Bladder Cancer.

    Reddy, Opal L / Cates, Justin M / Gellert, Lan L / Crist, Henry S / Yang, Zhaohai / Yamashita, Hironobu / Taylor, John A / Smith, Joseph A / Chang, Sam S / Cookson, Michael S / You, Chaochen / Barocas, Daniel A / Grabowska, Magdalena M / Ye, Fei / Wu, Xue-Ru / Yi, Yajun / Matusik, Robert J / Kaestner, Klaus H / Clark, Peter E /
    DeGraff, David J

    The American journal of pathology

    2015  Volume 185, Issue 5, Page(s) 1385–1395

    Abstract: We previously found loss of forkhead box A1 (FOXA1) expression to be associated with aggressive urothelial carcinoma of the bladder, as well as increased tumor proliferation and invasion. These initial findings were substantiated by The Cancer Genome ... ...

    Abstract We previously found loss of forkhead box A1 (FOXA1) expression to be associated with aggressive urothelial carcinoma of the bladder, as well as increased tumor proliferation and invasion. These initial findings were substantiated by The Cancer Genome Atlas, which identified FOXA1 mutations in a subset of bladder cancers. However, the prognostic significance of FOXA1 inactivation and the effect of FOXA1 loss on urothelial differentiation remain unknown. Application of a univariate analysis (log-rank) and a multivariate Cox proportional hazards regression model revealed that loss of FOXA1 expression is an independent predictor of decreased overall survival. An ubiquitin Cre-driven system ablating Foxa1 expression in urothelium of adult mice resulted in sex-specific histologic alterations, with male mice developing urothelial hyperplasia and female mice developing keratinizing squamous metaplasia. Microarray analysis confirmed these findings and revealed a significant increase in cytokeratin 14 expression in the urothelium of the female Foxa1 knockout mouse and an increase in the expression of a number of genes normally associated with keratinocyte differentiation. IHC confirmed increased cytokeratin 14 expression in female bladders and additionally revealed enrichment of cytokeratin 14-positive basal cells in the hyperplastic urothelial mucosa in male Foxa1 knockout mice. Analysis of human tumor specimens confirmed a significant relationship between loss of FOXA1 and increased cytokeratin 14 expression.
    MeSH term(s) Aged ; Animals ; Biomarkers, Tumor/metabolism ; Carcinoma, Transitional Cell/metabolism ; Carcinoma, Transitional Cell/mortality ; Carcinoma, Transitional Cell/pathology ; Cell Differentiation/physiology ; Disease Models, Animal ; Female ; Hepatocyte Nuclear Factor 3-alpha/metabolism ; Humans ; Immunohistochemistry ; Kaplan-Meier Estimate ; Keratin-14 ; Male ; Mice ; Mice, Knockout ; Middle Aged ; Oligonucleotide Array Sequence Analysis ; Prognosis ; Proportional Hazards Models ; Sex Characteristics ; Tissue Array Analysis ; Transcriptome ; Urinary Bladder Neoplasms/metabolism ; Urinary Bladder Neoplasms/mortality ; Urinary Bladder Neoplasms/pathology ; Urothelium/pathology
    Chemical Substances Biomarkers, Tumor ; FOXA1 protein, human ; Hepatocyte Nuclear Factor 3-alpha ; Keratin-14
    Language English
    Publishing date 2015-01-30
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2943-9
    ISSN 1525-2191 ; 0002-9440
    ISSN (online) 1525-2191
    ISSN 0002-9440
    DOI 10.1016/j.ajpath.2015.01.014
    Database MEDical Literature Analysis and Retrieval System OnLINE

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