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  1. Article ; Online: TARGT Gene Therapy Platform for Correction of Anemia in End-Stage Renal Disease.

    Blum, Shany / Shapir, Nir / Miari, Reem / Lerner, Benny / Koren, Belly / Doenyas-Barak, Keren / Efrati, Shai / Pergola, Pablo E / Schwartz, Doron / Chernin, Gil / Yagil, Yoram / Guzy, Serge / Nyska, Abraham / Neil, Garry A

    The New England journal of medicine

    2017  Volume 376, Issue 2, Page(s) 189–191

    MeSH term(s) Anemia/etiology ; Anemia/therapy ; Animals ; Drug Implants ; Erythropoietin/blood ; Erythropoietin/secretion ; Genetic Therapy/methods ; Hemoglobins/analysis ; Humans ; Kidney Failure, Chronic/complications ; Kidney Failure, Chronic/therapy ; Mice ; Renal Dialysis
    Chemical Substances Drug Implants ; Hemoglobins ; Erythropoietin (11096-26-7)
    Language English
    Publishing date 2017--12
    Publishing country United States
    Document type Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1606202
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.34: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Phase I study of multi-gene cell therapy in patients with peripheral artery disease.

    Grossman, P Michael / Mohler, Emile R / Roessler, Blake J / Wilensky, Robert L / Levine, Bruce L / Woo, Edward Y / Upchurch, Gilbert R / Schneiderman, Jacob / Koren, Belly / Hutoran, Marina / Gershstein, Diana / Flugelman, Moshe Y

    Vascular medicine (London, England)

    2016  Volume 21, Issue 1, Page(s) 21–32

    Abstract: Unlabelled: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label ... ...

    Abstract Unlabelled: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 10(7), Cohort 2: 2 × 10(7), Cohort 3: 5 × 10(7), Cohort 4: 7 × 10(7)). The treatment was given unblinded and in the more symptomatic lower extremity. Transduced cells were tested for in vitro doubling time, telomerase activity, and gene expression. The main outcomes were clinical safety and tolerability. Other safety measures included ankle-brachial index (ABI) and walking time on a treadmill. All subjects were male (mean age 60 ± 5 years) including 25% with diabetes mellitus. At 1-year follow-up, there was one serious adverse event possibly related to MGA. Safety endpoints including VEGF and Ang-1 plasma protein levels were within normal ranges in all subjects. The mean maximal walking time increased from baseline to 1 year and the index limb ABI was unchanged, indicating no safety concerns. MGA, an autologous, transduced, cell-based therapy was well tolerated and safe in this Phase I study. Further evaluation is warranted in randomized human studies.
    Clinical trial registration: ClinicalTrials.gov Identifier: NCT00390767.
    MeSH term(s) Aged ; Angiogenic Proteins/biosynthesis ; Angiogenic Proteins/genetics ; Angiopoietin-1/biosynthesis ; Angiopoietin-1/genetics ; Ankle Brachial Index ; Cell Proliferation ; Cell Transplantation/methods ; Cells, Cultured ; Endothelial Cells/metabolism ; Endothelial Cells/transplantation ; Exercise Test ; Exercise Tolerance ; Genetic Therapy/methods ; Humans ; Intermittent Claudication/diagnosis ; Intermittent Claudication/genetics ; Intermittent Claudication/metabolism ; Intermittent Claudication/physiopathology ; Intermittent Claudication/surgery ; Male ; Michigan ; Middle Aged ; Myocytes, Smooth Muscle/metabolism ; Myocytes, Smooth Muscle/transplantation ; Neovascularization, Physiologic ; Pennsylvania ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/genetics ; Peripheral Arterial Disease/metabolism ; Peripheral Arterial Disease/physiopathology ; Peripheral Arterial Disease/surgery ; Recovery of Function ; Telomerase/metabolism ; Time Factors ; Transduction, Genetic ; Treatment Outcome ; Vascular Endothelial Growth Factor A/biosynthesis ; Vascular Endothelial Growth Factor A/genetics
    Chemical Substances ANGPT1 protein, human ; Angiogenic Proteins ; Angiopoietin-1 ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; Telomerase (EC 2.7.7.49)
    Language English
    Publishing date 2016-02
    Publishing country England
    Document type Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural
    ZDB-ID 1311628-9
    ISSN 1477-0377 ; 1358-863X
    ISSN (online) 1477-0377
    ISSN 1358-863X
    DOI 10.1177/1358863X15612148
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 4409: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article: Viral vectors for vascular gene therapy.

    Fischer, Lukas / Preis, Meir / Weisz, Anat / Koren, Belly / Lewis, Basil S / Flugelman, Moshe Y

    Experimental and clinical cardiology

    2009  Volume 7, Issue 2-3, Page(s) 106–112

    Abstract: Vascular gene therapy is the focus of multiple experimental and clinical research efforts. While several genes with therapeutic potential have been identified, the best method of gene delivery is unknown. Viral vectors have the capacity to transfer genes ...

    Abstract Vascular gene therapy is the focus of multiple experimental and clinical research efforts. While several genes with therapeutic potential have been identified, the best method of gene delivery is unknown. Viral vectors have the capacity to transfer genes at high efficiency rates. Several viral-based vectors have been used in experimental vascular gene therapy for in vivo and ex vivo gene transfer. Adenoviral-based vectors are being used for the induction of angiogenesis in phase 1 and 2 clinical trials. In the present review, the characteristics of the 'ideal' viral vector are discussed and the major types of viral vectors used in vascular gene transfer are reviewed. Basic knowledge of the use of viral vectors for direct in vivo gene transfer (adenoviral-based vectors, etc) and for ex vivo gene transfer (retroviral-based vectors) is provided. New developments in the field of viral vectorology, such as pseudotyping of retroviral vectors and targeting of other viral vectors to a specific cell type, will enhance the more rapid transition of vascular gene therapy from the experimental arena to the clinical setting.
    Language English
    Publishing date 2009-07-30
    Publishing country Canada
    Document type Journal Article
    ZDB-ID 2061162-6
    ISSN 1205-6626
    ISSN 1205-6626
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6009: Show issues Location:
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  4. Article ; Online: Phase Ib Safety, Two-Dose Study of MultiGeneAngio in Patients with Chronic Critical Limb Ischemia.

    Flugelman, Moshe Y / Halak, Moshe / Yoffe, Boris / Schneiderman, Jacob / Rubinstein, Chen / Bloom, Allan-Isaac / Weinmann, Eran / Goldin, Ilya / Ginzburg, Victor / Mayzler, Olga / Hoffman, Aaron / Koren, Belly / Gershtein, Diana / Inbar, Michal / Hutoran, Marina / Tsaba, Adili

    Molecular therapy : the journal of the American Society of Gene Therapy

    2017  Volume 25, Issue 3, Page(s) 816–825

    Abstract: Critical limb ischemia (CLI) is the most severe presentation of peripheral arterial disease. We developed cell-based therapy entailing intra-arterial injection of autologous venous endothelial cells (ECs) modified to express angiopoietin 1, combined with ...

    Abstract Critical limb ischemia (CLI) is the most severe presentation of peripheral arterial disease. We developed cell-based therapy entailing intra-arterial injection of autologous venous endothelial cells (ECs) modified to express angiopoietin 1, combined with autologous venous smooth muscle cells (SMCs) modified to express vascular endothelial growth factor. This combination promoted arteriogenesis in animal models and was safe in patients with limiting claudication. In an open-label, phase Ib study, we assessed the safety and efficacy of this therapy in CLI patients who failed or were unsuitable for surgery or intravascular intervention. Of 23 patients enrolled, 18 with rest pain or non-healing ulcers (Rutherford categories 4 and 5) were treated according to protocol, and 5 with significant tissue loss (Rutherford 6) were treated under compassionate treatment. Patients were assigned randomly to receive 1 × 10
    MeSH term(s) Aged ; Aged, 80 and over ; Angiogenic Proteins/genetics ; Combined Modality Therapy ; Endothelial Cells/metabolism ; Female ; Gene Expression ; Gene Transfer Techniques ; Genetic Therapy/adverse effects ; Genetic Therapy/methods ; Genetic Vectors/administration & dosage ; Genetic Vectors/genetics ; Humans ; Ischemia/diagnosis ; Ischemia/etiology ; Ischemia/genetics ; Ischemia/therapy ; Lower Extremity/blood supply ; Male ; Middle Aged ; Myocytes, Smooth Muscle/metabolism ; Quality of Life ; Retroviridae/genetics ; Transduction, Genetic ; Transgenes ; Treatment Outcome
    Chemical Substances Angiogenic Proteins
    Language English
    Publishing date 2017-03-01
    Publishing country United States
    Document type Clinical Trial, Phase I ; Journal Article
    ZDB-ID 2010592-7
    ISSN 1525-0024 ; 1525-0016
    ISSN (online) 1525-0024
    ISSN 1525-0016
    DOI 10.1016/j.ymthe.2016.12.019
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5640: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (2.OG)
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  5. Article: Endothelial cells are activated by angiopoeitin-1 gene transfer and produce coordinated sprouting in vitro and arteriogenesis in vivo.

    Gluzman, Zoya / Koren, Belly / Preis, Meir / Cohen, Tzafra / Tsaba, Adili / Cosset, Francois-Loic / Shofti, Rona / Lewis, Basil S / Virmani, Renu / Flugelman, Moshe Y

    Biochemical and biophysical research communications

    2007  Volume 359, Issue 2, Page(s) 263–268

    Abstract: Rational and objectives: Activation of fully differentiated vascular cells using angiogenic genes can lead to phenotypic changes resulting in formation of new blood vessels. We tested whether Ang-1 gene transfer to endothelial cells (EC) activates these ...

    Abstract Rational and objectives: Activation of fully differentiated vascular cells using angiogenic genes can lead to phenotypic changes resulting in formation of new blood vessels. We tested whether Ang-1 gene transfer to endothelial cells (EC) activates these cells.
    Methods and results: EC and SMC were transduced using retroviral or adenoviral vectors to produce Ang-1 or vascular endothelial growth factor (VEGF). EC Tie-2 receptor was phosphorilated by autologous secretion of Ang-1. Transduced EC and SMC sprouting capacity was tested using collagen embedded spheroids assay and capacity to produce arteriogenesis was tested in a hind limb model of ischemia. EC expressing Ang-1 in the presence of SMC expressing VEGF exhibited high levels of sprouting of the two cell types. Flow and numbers of arteries were increased after transduced cells implantation in vivo.
    Conclusions: Autologous secretion of Ang-1 by transduced EC resulted in Tie-2 activation and in the presence of SMC expressing VEGF resulted in coordinated sprouting in vitro and increase in flow and number of arteries in vivo.
    MeSH term(s) Adenoviridae/genetics ; Angiopoietin-1/biosynthesis ; Angiopoietin-1/genetics ; Animals ; Arteries/metabolism ; Arteries/pathology ; Biopsy ; DNA, Complementary/metabolism ; Endothelial Cells/cytology ; Endothelial Cells/metabolism ; Gene Transfer Techniques ; Humans ; Myocytes, Smooth Muscle/cytology ; Neovascularization, Pathologic ; Phosphorylation ; Retroviridae/genetics ; Swine ; Vascular Endothelial Growth Factor A/metabolism
    Chemical Substances Angiopoietin-1 ; DNA, Complementary ; Vascular Endothelial Growth Factor A
    Language English
    Publishing date 2007-07-27
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 205723-2
    ISSN 0006-291X ; 0006-291X
    ISSN (online) 0006-291X
    ISSN 0006-291X
    DOI 10.1016/j.bbrc.2007.05.097
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 116: Show issues Location:
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  6. Article: Efficient transduction and seeding of human endothelial cells onto metallic stents using bicistronic pseudo-typed retroviral vectors encoding vascular endothelial growth factor.

    Koren, Belly / Weisz, Anat / Fischer, Lukas / Gluzman, Zoya / Preis, Meir / Avramovitch, Naomi / Cohen, Tzafra / Cosset, Francois-Loic / Lewis, Basil S / Flugelman, Moshe Y

    Cardiovascular revascularization medicine : including molecular interventions

    2006  Volume 7, Issue 3, Page(s) 173–178

    Abstract: Background: Stents seeded with genetically modified endothelial cells (EC) may provide an attractive therapeutic modality for treating vascular diseases by combining the mechanical properties of the metallic stent with the biologic activity of native or ...

    Abstract Background: Stents seeded with genetically modified endothelial cells (EC) may provide an attractive therapeutic modality for treating vascular diseases by combining the mechanical properties of the metallic stent with the biologic activity of native or genetically engineered ECs. The clinical feasibility of implanting seeded stents depends on the ability to achieve adequate stent coverage within a clinically applicable time frame. We tested the hypothesis that this goal could be achieved by seeding stents with human ECs overexpressing vascular endothelial growth factor (VEGF) and by using an efficient gene transfer system.
    Methods and results: Efficiency of gene transfer to human ECs using an amphotropic retroviral vector and a gibbon ape leukemia virus (GALV) pseudo-typed retroviral vector was examined and compared. For assessment of transduction rates, LacZ-encoding vectors were used and beta-galactosidase activity was determined 48 h after gene transfer. The transduction rate of primary human ECs using the amphotropic retroviral vector encoding the LacZ gene was low (2.9+/-2% of cells). Under the same conditions, the GALV pseudo-typed vector encoding LacZ transduced 94+/-2% of cells (P<.001). To test the effect of VEGF gene transfer on stent coverage, we transduced ECs using a bicistronic GALV pseudo-typed retroviral vector encoding either GFP alone or both VEGF and GFP. Since all transduced cells expressed GFP, stent coverage by ECs could be assessed by fluorescent inverted microscopy, which demonstrated that stent coverage by ECs overexpressing VEGF was more rapid and effective than coverage by ECs overexpressing GFP. Progressively increasing quantities of VEGF protein were detected in the conditioned medium of stents seeded with endothelia cells expressing VEGF 2, 3, and 5 days after seeding.
    Conclusions: High-rate gene transfer to human primary ECs was observed 48 h after transduction with GALV pseudo-typed retroviral vectors, eliminating the need for the time-consuming process of cell selection. Seeding with ECs overexpressing VEGF improved stent coverage and was associated with continuing secretion of the protein. The findings provide support for the feasibility of implanting genetically engineered biologically active cellular-coated stents.
    MeSH term(s) Blood Vessel Prosthesis ; Blotting, Western ; Endothelial Cells/metabolism ; Endothelial Cells/virology ; Endothelium, Vascular/cytology ; Endothelium, Vascular/metabolism ; Endothelium, Vascular/surgery ; Enzyme-Linked Immunosorbent Assay ; Equipment Design ; Gene Transfer Techniques ; Genetic Engineering ; Genetic Vectors/genetics ; Genetic Vectors/therapeutic use ; Humans ; Lac Operon/genetics ; Leukemia Virus, Gibbon Ape/genetics ; Metals ; Saphenous Vein/cytology ; Saphenous Vein/metabolism ; Saphenous Vein/surgery ; Stents ; Transduction, Genetic ; Vascular Endothelial Growth Factor A/analysis ; Vascular Endothelial Growth Factor A/biosynthesis ; Vascular Endothelial Growth Factor A/genetics ; beta-Galactosidase/genetics ; beta-Galactosidase/metabolism
    Chemical Substances Metals ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; beta-Galactosidase (EC 3.2.1.23)
    Language English
    Publishing date 2006-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2212113-4
    ISSN 1553-8389
    ISSN 1553-8389
    DOI 10.1016/j.carrev.2005.12.007
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    Zs.A 5562: Show issues Location:
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