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  • 1
    Online Resource
    Online Resource
    Report of the international conference on manufacturing and testing of pluripotent stem cells
    Elsevier BV ; 2018
    In:  Biologicals Vol. 56 ( 2018-11), p. 67-83
    Details
    In: Biologicals, Elsevier BV, Vol. 56 ( 2018-11), p. 67-83
    Type of Medium: Online Resource
    ISSN: 1045-1056
    URL: Article
    DOI: 10.1016/j.biologicals.2018.08.004
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
    detail.hit.zdb_id: 1462158-7
    SSG: 12
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  • 2
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    Challenging Regeneration to Transform Medicine
    Oxford University Press (OUP) ; 2016
    In:  Stem Cells Translational Medicine Vol. 5, No. 1 ( 2016-01-01), p. 1-7
    Details
    In: Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 5, No. 1 ( 2016-01-01), p. 1-7
    Abstract: The aging population in the U.S. and other developed countries has led to a large increase in the number of patients suffering from degenerative diseases. Transplantation surgery has been a successful therapeutic option for certain patients; however, the availability of suitable donor organs and tissues significantly limits the number of patients who can benefit from this approach. Regenerative medicine has witnessed numerous recent and spectacular advances, making the repair or replacement of dysfunctional organs and tissues an achievable goal. Public-private partnerships and government policies and incentives would further catalyze the development of universally available donor tissues, resulting in broad medical and economic benefits. This article describes a Regenerative Medicine Grand Challenge that the Alliance for Regenerative Medicine recently shared with the White House's Office of Science and Technology Policy in response to a White House call to action in scientific disciplines suggesting that the development of “universal donor tissues” should be designated as a Regenerative Medicine Grand Challenge. Such a designation would raise national awareness of the potential of regenerative medicine to address the unmet needs of many diseases and would stimulate the scientific partnerships and investments in technology needed to expedite this goal. Here we outline key policy changes and technological challenges that must be addressed to achieve the promise of a major breakthrough in the treatment of degenerative disease. A nationalized effort and commitment to develop universal donor tissues could realize this goal within 10 years and along the way result in significant innovation in manufacturing technologies. Significance Regenerative therapies, in which dysfunctional or degenerating cells, tissues, or organs are repaired or replaced, have the potential to cure chronic degenerative diseases. Such treatments are limited by a shortage of donor organs and tissues and the need for immune suppression to prevent rejection. This article proposes a 21st Century Grand Challenge that would address this significant medical need by coordinating a national effort to convene the multidisciplinary expertise needed to manufacture functional and engraftable cells, tissues, or organs that could be made available to any patient without significant risk of rejection—so-called universal donor tissues.
    Type of Medium: Online Resource
    ISSN: 2157-6564 , 2157-6580
    URL: Article
    DOI: 10.5966/sctm.2015-0180
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2016
    detail.hit.zdb_id: 2642270-0
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  • 3
    Online Resource
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    Human placenta‐derived adherent cells induce tolerogenic immune responses
    Wiley ; 2014
    In:  Clinical & Translational Immunology Vol. 3, No. 5 ( 2014-05)
    Details
    In: Clinical & Translational Immunology, Wiley, Vol. 3, No. 5 ( 2014-05)
    Abstract: The same mechanisms that protect the fetus from the mother's immune system could help keep autoimmune and inflammatory diseases at bay. A growing body of evidence suggests that placental cells promote maternal tolerance for fetal tissues that might otherwise be perceived as ‘foreign’. Bitao Liang and colleagues at Celgene Cellular Therapeutics in Warren, New Jersey, USA, examined the role of cultured human ‘placenta‐derived adherent cells’ (PDAC® cells), with a view toward developing these cells as therapeutic tools. Cell culture and animal model experiments both demonstrated that PDAC® cells can help restrict proliferation and activation of T‐cell subsets associated with certain immune disorders. The authors found that this occurs through direct effects on T cells and also through factors secreted by PDAC® cells. These factors promote development of particular immune cells that help limit the overall immune response.
    Type of Medium: Online Resource
    ISSN: 2050-0068 , 2050-0068
    URL: Article
    DOI: 10.1038/cti.2014.5
    Language: English
    Publisher: Wiley
    Publication Date: 2014
    detail.hit.zdb_id: 2694482-0
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  • 4
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    Human Placenta-Derived Adherent Cells Delivered Intralesionally Inhibit Myeloma Bone Disease and Tumor Growth, While Intravenously Are Capable of Trafficking to Myelomatous Bone.
    American Society of Hematology ; 2010
    In:  Blood Vol. 116, No. 21 ( 2010-11-19), p. 3717-3717
    Details
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 3717-3717
    Abstract: Abstract 3717 Human placenta has emerged as a valuable, uncontroversial source of transplantable cells for many cytotherapeutic purposes, including modulation of inflammation, bone repair, and cancer. Placenta-derived adherent cells (PDAC) are mesenchymal like adherent cells isolated from postpartum human placenta and capable of supporting bone formation in vivo. Multiple myeloma (MM) is closely associated with induction of bone disease and large lytic lesions, which are often not repaired and are usually the sites of relapses. The aim of the study was to evaluate the antimyeloma therapeutic potential, in vivo survival, and trafficking of PDAC in the SCID-rab model of MM-associated bone disease. SCID-rab system constructed by implanting a 4-weeks old rabbit bone into which primary human myeloma cells were directly injected (Yatta et al., Leukemia 2004; Yaccoby et al., Blood 2007). Bone disease was evaluated by measurements of bone mineral density (BMD) and X-rays. MM growth was determined by human immunoglobulin (hIg) ELISA and histologically. For in vivo tracking PDAC were transduced with a luciferase/GFP reporter in a lentiviral vector. SCID-rab mice engrafted with primary myeloma cells from 2 patients. Upon establishment of MM growth, PDAC (1×106 cells/bone) or vehicle were injected into the implanted myelomatous bone (Patient's 1, 5 mice/group; Patient's 2, 7 mice/group). While BMD of the implanted bones was significantly reduced in control hosts, intralesional PDAC cytotherapy significantly increased BMD of the implanted bones from pretreatment levels by 〉 37% (p 〈 0.01 versus control) and inhibited MM growth in the 2 sets of experiments (p 〈 0.04). The bone anabolic effect of PDAC was associated with increased number of osteoblasts (p 〈 0.003) and reduced number of osteoclasts (p 〈 0.004). Intralesional PDAC cytotherapy also promoted bone formation in nonmyelomatous SCID-rab mice. Intralesional but not subcutaneous engraftment of PDAC inhibited bone disease and tumor growth in SCID-rab mice. In contrast to intra-bone injection in SCID-rab mice, intra-tumor injection of PDAC had no effect on subcutaneous growth of the H929 myeloma cell line in SCID mice (8 mice/group). Live-animal imaging revealed that the majority of PDAC disappeared from the injected bones within 4 weeks. To test their systemic behavior, PDAC were intravenously injected into 18 SCID-rab mice engrafted with H929 myeloma cells. The presences of PDAC in various organs were evaluated 1, 2 and 7 days after injection. Ex vivo bioluminescence analysis of the implanted myelomatous bones detected PDAC in two of five bones on day 1, in four of four bones on day 2, and in four of nine bones on day 7. Intravenously injected PDAC were also detected in lungs not in any other murine tissues. Immunohistochemical staining for GFP in myelomatous bone sections detected GFP-expressing PDAC in rabbit marrow areas infiltrated with myeloma cells, supporting bioluminescence analysis. Our study suggest that PDAC stimulate bone formation by acting as bystander cells that increase endogenous osteoblastogenesis and inhibit osteoclastogenesis, and that alteration of the bone marrow microenvironment by PDAC attenuates growth of MM. PDAC cytotherapy is a promising therapeutic approach for myeloma bone disease. Disclosures: Khan: Celgene Cellular Therapeutics: Research Funding. Heidaran:Celgene Cellular Therapeutics: Employment. Pal:Celgene Cellular Therapeutics: Employment. Zhang:Celgene Cellular Therapeutics: Employment. He:Celgene Cellular Therapeutics: Employment. Zeitlin:Celgene Cellular Therapeutics: Employment. Abbot:Celgene Cellular Therapeutics: Employment. Faleck:Celgene Cellular Therapeutics: Employment. Hariri:Celgene Cellular Therapeutics: Employment.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V116.21.3717.3717
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 5
    Online Resource
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    Genetically Enhanced Pluripotent Stem Cell-Derived T Lymphocytes for Off-the-Shelf Cellular Immunotherapy
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 2164-2164
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 2164-2164
    Abstract: Cellular immunotherapies are poised to transform the treatment of cancer and immunological disorders. In the most promising setting to date, genetic modification to the T lymphocytes in the form of chimeric antigen receptors (CAR) has dramatically increased therapeutic efficacy with reported initial complete remission rates in acute lymphoblastic leukemia ranging between 80-100%. However, pressing challenges remain to be solved to ensure that engineered T-cell immunotherapies can be cost-effectively and consistently manufactured, and safely and reliably delivered at the scale necessary to support wide patient base commercialization. Human induced pluripotent stem cell (hiPSC) derived T lymphocytes represent a unique, renewable source of genetically engineered T cells for "off-the-shelf" immunotherapy. Through the precise genetic engineering at the hiPSC stage, clonal and uniform populations of modified cell lines can be banked and reliably tapped into on demand to generate highly efficacious T cells for therapeutic applications. Although great progress has been made, several challenges need to be addressed including the ability to enhance effector function through genome-engineering of persistence, targeting, histocompatibility and controlled safety mechanisms at the hiPSC juncture while retaining the capacity to efficiently and reproducibly generate the intricate stages of lymphocyte development in an accurate and scalable process. We have previously demonstrated that our proprietary reprogramming platform supports efficient and rapid derivation of clonal hiPSC lines with properties indicative of the naïve state of pluripotency. In addition to maintaining a homogeneous population of hiPSCs, our platform enables efficient multi-gene and multi-loci targeted engineering at a single cell level resulting in clonal population of pluripotent cell lines with desired genetic attributes. Here we will provide an update on our "off-the-shelf" T-cell immunotherapy preclinical program where engineered hiPSC lines are uniquely used as the renewable starting material. We will also highlight our novel differentiation platform to derive definitive hematopoietic progenitor cells termed hemogenic endothelium (HE); a well-defined, small molecule-driven, staged process that is currently being translated into cGMP (current good manufacturing practice) settings. The highly efficient differentiation system (on average 〉 65% hiPSC to CD34 conversion) delivers approximately 100 CD34+ HE cells per each input hiPSC, representing a highly scalable process that is further expanded during lymphocyte differentiation and maturation. To validate that the iCD34+ HE is definitive in nature we demonstrate that during further hematopoietic differentiation the emerging CD43+ hematopoietic cells exhibit Notch dependency and high expression of key genes such as MYB and the HOXA cluster, found only in definitive hematopoietic progenitors. The hiPSC-derived HE exhibits multi-lineage potential and can be successfully cryopreserved and banked, serving as a highly-stable cell bank for subsequent therapeutic use. Through genetic modifications at the single cell hiPSC stage, we confer antigen-specificity via the expression of temporally inducible CARs as premature expression of CAR proteins during in vitro differentiation has been found to skew development towards innate-lymphoid like lineages. Utilizing our stage-specific hematopoietic differentiation platform we have identified the optimal developmental window to induce the expression of CAR proteins to maintain optimal differentiation towards functional effector lymphocytes. The hiPSC-derived engineered T lymphocytes are currently under preclinical investigation for in vitro and in vivo effector function including thymic rejuvenation, T cell repertoire repopulation, target specific recognition and enhanced killing potential. Preliminary data suggests that hiPSC-derived lymphocytes are functional and can home to their respective niche to support initial repopulation in vivo. Our study continues to support that naïve hiPSCs are an ideal renewal source for "off-the-shelf" hematopoietic cell-based immunotherapies and represent a potentially exponential advancement in adoptive T cell therapy. Disclosures Clarke: Fate Therapeutics: Employment. Groff:Fate Therapeutics: Employment. Sasaki:Fate Therapeutics: Employment. Bauer:Fate Therapeutics: Employment. Lee:Fate Therapeutics: Employment. Lan:Fate Therapeutics: Employment. Burrascano:Fate Therapeutics: Employment. Abujarour:Fate Therapeutics: Employment. Bonello:Fate Therapeutics: Employment. Robinson:Fate Therapeutics: Employment. Foster:Fate Therapeutics: Employment, Equity Ownership. Robbins:Fate Therapeutics: Employment, Equity Ownership. Wolchko:Fate Therapeutics: Employment. Shoemaker:Fate Therapeutics: Employment, Equity Ownership. Abbot:Fate Therapeutics: Employment. Valamehr:Fate Therapeutics, Inc: Employment.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.2164.2164
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 6
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    Online Resource
    Allogeneic Vδ1 gamma delta T cells engineered with glypican-3 (GPC3)-specific CAR expressing soluble IL-15 have enhanced antitumor efficacy against hepatocellular carcinoma in preclinical models.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e14511-e14511
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e14511-e14511
    Abstract: e14511 Background: Autologous αβ chimeric antigen receptor (CAR) T cell therapy has shown promising clinical results in hematologic malignancies but limited success in solid tumors. Allogeneic αβ T cell therapy may overcome several challenges faced by autologous therapy but carries the risk of graft-versus-host disease (GvHD) and does not readily recognize multiple tumor-associated antigens. Gamma delta (γδ) T cells are highly cytolytic effectors that can recognize and kill tumor cells in an MHC-unrestricted manner without causing GvHD. The Vδ1 subset is preferentially localized in peripheral tissue and is critical for tumor immunosurveillance. Engineering Vδ1 T cells with CARs can further enhance antitumor activity and represents an attractive and safe approach to treating solid tumors. However, their clinical use has been hindered by the limited number of circulating Vδ1 T cells. Here, we describe the development of the first allogeneic Vδ1 T cells that have been expanded from healthy donor PBMCs and genetically modified to secrete IL-15 (sIL15) and express a CAR targeting glypican-3 (GPC3), a rational target for hepatocellular carcinoma (HCC). Methods: Vδ1 T cells in healthy donor PBMCs were activated by a Vδ1-specific monoclonal antibody and transduced with 41BBζ or 41BBζ-sIL15 GPC3-CARs prior to cell expansion, αβ T cell depletion and cryopreservation. In vitro characterization included: 1) co-culture assays with GPC3-expressing HCC targets HepG2 and PLC/PRF/5, 2) phenotypic analysis by flow cytometry, and 3) cytokine production by multiplexed immunoassay. For in vivo assessment of tumor control, immunodeficient NSG mice were subcutaneously injected with HepG2 cells and treated with a single dose of 41BBζ or 41BBζ-sIL15 GPC3-CAR Vδ1 T cells. Additionally, tissues were harvested 7 days post transfer and analyzed by flow cytometry for Vδ1 T cell tissue homing and proliferation, or at end of study and analyzed for GvHD by immunohistochemistry. Results: Vδ1 T cells expanded over 10,000-fold and routinely reached 〉 80% purity. Expanded Vδ1 T cells showed a primarily naïve-like phenotype (CD45RA+CD27+) with minimal exhaustion receptor expression and displayed robust proliferation, cytokine production, and cytotoxic activity against HCC cell lines expressing low and high GPC3 levels in vitro. In a HepG2 mouse model, GPC3-CAR Vδ1 T cells primarily accumulated and proliferated in the tumor, and a single dose was able to efficiently control tumor burden without causing GvHD. Importantly, 41BBζ-sIL15 GPC3-CAR Vδ1 cells displayed enhanced tumor-specific proliferation that resulted in better tumor control without any toxicity. Conclusions: Our results show that expanded Vδ1 T cells engineered with GPC3-CAR and sIL-15 represent a promising platform for safe and effective off-the-shelf treatment of HCC.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e14511
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
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  • 7
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    Online Resource
    Magnetic fields from electric power lines: theory and comparison to measurements
    Institute of Electrical and Electronics Engineers (IEEE) ; 1988
    In:  IEEE Transactions on Power Delivery Vol. 3, No. 4 ( 1988-Oct.), p. 2127-2136
    Details
    In: IEEE Transactions on Power Delivery, Institute of Electrical and Electronics Engineers (IEEE), Vol. 3, No. 4 ( 1988-Oct.), p. 2127-2136
    Type of Medium: Online Resource
    ISSN: 0885-8977
    URL: Article
    DOI: 10.1109/61.194025
    Language: Unknown
    Publisher: Institute of Electrical and Electronics Engineers (IEEE)
    Publication Date: 1988
    detail.hit.zdb_id: 2027539-0
    detail.hit.zdb_id: 165807-4
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  • 8
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    The Three “R”s of Blood Transfusion in 2020; Routine, Reliable and Robust
    Elsevier BV ; 2010
    In:  Clinics in Laboratory Medicine Vol. 30, No. 2 ( 2010-6), p. 405-417
    Details
    In: Clinics in Laboratory Medicine, Elsevier BV, Vol. 30, No. 2 ( 2010-6), p. 405-417
    Type of Medium: Online Resource
    ISSN: 0272-2712
    URL: Article
    DOI: 10.1016/j.cll.2010.02.010
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2010
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  • 9
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    Plant-Produced Human Recombinant Erythropoietic Growth Factors Support Erythroid Differentiation In Vitro
    Mary Ann Liebert Inc ; 2013
    In:  Stem Cells and Development Vol. 22, No. 16 ( 2013-08-15), p. 2326-2340
    Details
    In: Stem Cells and Development, Mary Ann Liebert Inc, Vol. 22, No. 16 ( 2013-08-15), p. 2326-2340
    Type of Medium: Online Resource
    ISSN: 1547-3287 , 1557-8534
    URL: Article
    DOI: 10.1089/scd.2012.0489
    Language: English
    Publisher: Mary Ann Liebert Inc
    Publication Date: 2013
    detail.hit.zdb_id: 2142305-2
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  • 10
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    Differentiating Human Embryonic Stem Cells Express a Unique Housekeeping Gene Signature
    Oxford University Press (OUP) ; 2007
    In:  Stem Cells Vol. 25, No. 2 ( 2007-02-01), p. 473-480
    Details
    In: Stem Cells, Oxford University Press (OUP), Vol. 25, No. 2 ( 2007-02-01), p. 473-480
    Abstract: Housekeeping genes (HKGs) are involved in basic functions needed for the sustenance of the cell and are assumed to be constitutively expressed at a constant level. Based on these features, HKGs are frequently used for normalization of gene expression data. In the present study, we used the CodeLink Gene Expression Bioarray system to interrogate changes in gene expression occurring during differentiation of human ESCs (hESCs). Notably, in the three hESC lines used for the study, we observed that the RNA levels of 56 frequently used HKGs varied to a degree that rendered them inappropriate as reference genes. Therefore, we defined a novel set of HKGs specifically for hESCs. Here we present a comprehensive list of 292 genes that are stably expressed (coefficient of variation & lt;20%) in differentiating hESCs. These genes were further grouped into high-, medium-, and low-expressed genes. The expression patterns of these novel HKGs show very little overlap with results obtained from somatic cells and tissues. We further explored the stability of this novel set of HKGs in independent, publicly available gene expression data from hESCs and observed substantial similarities with our results. Gene expression was confirmed by real-time quantitative polymerase chain reaction analysis. Taken together, these results suggest that differentiating hESCs have a unique HKG signature and underscore the necessity to validate the expression profiles of putative HKGs. In addition, this novel set of HKGs can preferentially be used as controls in gene expression analyses of differentiating hESCs.
    Type of Medium: Online Resource
    ISSN: 1066-5099 , 1549-4918
    URL: Article
    DOI: 10.1634/stemcells.2006-0247
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2007
    detail.hit.zdb_id: 2030643-X
    detail.hit.zdb_id: 1143556-2
    detail.hit.zdb_id: 605570-9
    SSG: 12
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