Immunostimulating Agent

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Kurt G. Naber - One of the best experts on this subject based on the ideXlab platform.

  • Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study
    World Journal of Urology, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III. Methods Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo. Results Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p  = 0.59; PPS: p  = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa. Conclusions This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated. EudraCT 2007-004609-85.

  • Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study.
    World journal of urology, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

  • MP16-04 IMMUNOSTIMULATION IN CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS). A ONE-YEAR PROSPECTIVE, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    European Urology Supplements, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

Florian M.e. Wagenlehner - One of the best experts on this subject based on the ideXlab platform.

  • Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study
    World Journal of Urology, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III. Methods Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo. Results Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p  = 0.59; PPS: p  = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa. Conclusions This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated. EudraCT 2007-004609-85.

  • Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study.
    World journal of urology, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

  • MP16-04 IMMUNOSTIMULATION IN CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS). A ONE-YEAR PROSPECTIVE, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    European Urology Supplements, 2014
    Co-Authors: Florian M.e. Wagenlehner, Stefania Ballarini, Kurt G. Naber
    Abstract:

    Purpose Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally Immunostimulating Agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

Ruizhan Chen - One of the best experts on this subject based on the ideXlab platform.

  • optimization of ultrasonic extraction process of polysaccharides from ornithogalum caudatum ait and evaluation of its biological activities
    Ultrasonics Sonochemistry, 2012
    Co-Authors: Ruizhan Chen, Yuan Li, Hang Dong, Shizhe Li, Simin Yang, Xinlong Li
    Abstract:

    Ultrasonic extraction technique (UET) was used to extract crude polysaccharides (OCAP) from Ornithogalum Caudatum Air (OCA), an orthogonal experiment (L-9 (3)(4)) was applied to optimize extraction conditions. Membrane separation technology and gel filtration chromatography were used to fractionate OCAP, the antioxidant and immunomodulatory activities were evaluated by radical scavenging and spleen lymphocyte proliferation assay. The optimal conditions were determined: extraction time 60 min, ultrasound power 500 W, ratio of water to raw material 30 ml/g and extraction number 3. Under these conditions, the yield of OCAP was 36.77 +/- 1.76%. OCAP was fractionated into three major fractions (OCAP-I, OCAP-II and OCAP-II), that all fractions possessed considerable antioxidant activity. OCAP-Il and OCAP-III exhibited good immunomodulatory activities. The results indicated that UET is a very useful method for extraction bioactive polysaccharides from plant materials. OCAP could be explored as a potential antioxidant and Immunostimulating Agent for use in medicine or functional foods. Crown Copyright (C) 2012 Published by Elsevier B.V. All rights reserved.

  • antioxidant and immunobiological activity of water soluble polysaccharide fractions purified from acanthopanax senticosu
    Food Chemistry, 2011
    Co-Authors: Ruizhan Chen, Zhiqiang Liu, Jimin Zhao, Ruiping Chen, Fanlei Meng, Min Zhang
    Abstract:

    Abstract A water-soluble polysaccharide obtained from Acanthopanax senticosus leaves (ASL), was fractionated by DEAE–Sepharose fast-flow column chromatography, and purified by Sephadex G-75 gel-permeation column chromatography. The characteristics of ASP-2-1 were determined by chemical analysis, high-performance capillary electrophoresis (HPCE), high-performance gel-permeation chromatography (HPGPC). The results show that ASP-2-1 contained 89.47% carbohydrate, 7.45% uronic acid, 2.16% protein and seven kinds of monosaccharides including rhamnose, xylose, glucose, mannose, arabinose, galactose and glucuronic acid in a molar ratio of 7.45:18.63:25.15:0.93:8.35:2.79:5.69, with an average molecular weight of about 14,573 Da. Furthermore, the immunobiological and antioxidant activities, in vitro, of ASP-2-1 were evaluated by MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay and ferric-reducing antioxidant power assay (FRAP), 2,2-diphenyl-1-picrylhydrazyl (DPPH ), superoxide radical ( O 2 - ) and hydroxyl radical ( OH) free radical-scavenging assay, respectively. The results showed that ASP-2-1 exhibited significantly higher immunomodulatory activities against the lymphocyte proliferation in vitro, pronounced reductive power (FRAP value: 785.1 μM at 0.2 mg/ml), strong hydroxyl radical (89.56% at 1 mg/ml) scavenging activity, moderate superoxide radicals (65.32% at 1 mg/ml) and DPPH radicals (68.9% at 1 mg/ml) scavenging activities. ASP-2-1 should be explored as a novel and potential natural antioxidant and Immunostimulating Agent for use in functional foods or medicine.

Min Zhang - One of the best experts on this subject based on the ideXlab platform.

  • antioxidant and immunobiological activity of water soluble polysaccharide fractions purified from acanthopanax senticosu
    Food Chemistry, 2011
    Co-Authors: Ruizhan Chen, Zhiqiang Liu, Jimin Zhao, Ruiping Chen, Fanlei Meng, Min Zhang
    Abstract:

    Abstract A water-soluble polysaccharide obtained from Acanthopanax senticosus leaves (ASL), was fractionated by DEAE–Sepharose fast-flow column chromatography, and purified by Sephadex G-75 gel-permeation column chromatography. The characteristics of ASP-2-1 were determined by chemical analysis, high-performance capillary electrophoresis (HPCE), high-performance gel-permeation chromatography (HPGPC). The results show that ASP-2-1 contained 89.47% carbohydrate, 7.45% uronic acid, 2.16% protein and seven kinds of monosaccharides including rhamnose, xylose, glucose, mannose, arabinose, galactose and glucuronic acid in a molar ratio of 7.45:18.63:25.15:0.93:8.35:2.79:5.69, with an average molecular weight of about 14,573 Da. Furthermore, the immunobiological and antioxidant activities, in vitro, of ASP-2-1 were evaluated by MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay and ferric-reducing antioxidant power assay (FRAP), 2,2-diphenyl-1-picrylhydrazyl (DPPH ), superoxide radical ( O 2 - ) and hydroxyl radical ( OH) free radical-scavenging assay, respectively. The results showed that ASP-2-1 exhibited significantly higher immunomodulatory activities against the lymphocyte proliferation in vitro, pronounced reductive power (FRAP value: 785.1 μM at 0.2 mg/ml), strong hydroxyl radical (89.56% at 1 mg/ml) scavenging activity, moderate superoxide radicals (65.32% at 1 mg/ml) and DPPH radicals (68.9% at 1 mg/ml) scavenging activities. ASP-2-1 should be explored as a novel and potential natural antioxidant and Immunostimulating Agent for use in functional foods or medicine.

Tim Niehues - One of the best experts on this subject based on the ideXlab platform.

  • An unspecific Immunostimulating Agent and juvenile dermatomyositis: enhanced T-cell proliferation and reverse immunosuppression as a severe adverse drug reaction.
    European journal of pediatrics, 2003
    Co-Authors: Gerd M. Lackmann, Jenny Ndagijimana, Tim Niehues
    Abstract:

    We report the case of an 8-year-old girl with juvenile dermatomyositis, whose disease course rapidly worsened under treatment with an unspecific Immunostimulating Agent containing large amounts of inosine. An 8-year-old girl had suffered from flat-topped papules over the dorsal interphalangeal joints for 1.5 years. As these papules were considered to be of viral origin, treatment with Delimmun, an unspecific Immunostimulating Agent containing 379.75 mg dimepranole4-acetoamidobenzoate and 120.25 mg inosine per tablet, was initiated 2 months previously. Under this therapy, the girl developed erythematous, scaling patches on the upper anterior chest and the extensor surfaces of her arms and legs as well as a violaceous erythema of the face in a ‘‘butterfly’’ distribution and purple-red discolouration of the upper eyelids. On admission to hospital, the papules on her hands were recognised as typical, so-called Gottron papules (Fig. 1), which are pathognomonic for dermatomyositis. Laboratory investigations were normal with the exception of slightly elevated transaminases (ASAT 29 U/l, reference range

  • an unspecific Immunostimulating Agent and juvenile dermatomyositis enhanced t cell proliferation and reverse immunosuppression as a severe adverse drug reaction
    European Journal of Pediatrics, 2003
    Co-Authors: Gerd M. Lackmann, Jenny Ndagijimana, Tim Niehues
    Abstract:

    We report the case of an 8-year-old girl with juvenile dermatomyositis, whose disease course rapidly worsened under treatment with an unspecific Immunostimulating Agent containing large amounts of inosine. An 8-year-old girl had suffered from flat-topped papules over the dorsal interphalangeal joints for 1.5 years. As these papules were considered to be of viral origin, treatment with Delimmun, an unspecific Immunostimulating Agent containing 379.75 mg dimepranole4-acetoamidobenzoate and 120.25 mg inosine per tablet, was initiated 2 months previously. Under this therapy, the girl developed erythematous, scaling patches on the upper anterior chest and the extensor surfaces of her arms and legs as well as a violaceous erythema of the face in a ‘‘butterfly’’ distribution and purple-red discolouration of the upper eyelids. On admission to hospital, the papules on her hands were recognised as typical, so-called Gottron papules (Fig. 1), which are pathognomonic for dermatomyositis. Laboratory investigations were normal with the exception of slightly elevated transaminases (ASAT 29 U/l, reference range <20 U/l; GPT 16 U/l, reference range <12 U/l) and muscle enzymes (LDH 373 U/l, reference range <200 U/l; CK 157 U/l, reference range <70 U/l). Immunological investigations showed normal values for immunoglobulins, complement factors, and most auto-antibodies, with the exception of elevated anti-nuclear antibodies (1:320, normal <1:160). HLA-class 1 typing showed type A3 A-B7 B15 (62) Cw3 Cw7; HLA b27 was negative. Serological investigations revealed negative titres against most bacteria and viruses. T2-weighted, Gadolinium-enhanced MRI of the thighs showed a pathological, inhomogeneous signal enhancement of all muscles, especially of the subsartorial canal. We started treatment with prednisolone (2 mg per kg body weight). Under this therapy, the skin lesions disappeared immediately. Pathological MRI findings completely normalised after 6 months of therapy. Juvenile dermatomyositis, a systemic vasculopathy, is the most common of the idiopathic inflammatory myopathies of childhood with unknown aetiology. The cutaneous signs of dermatomyositis may precede, like in our patient, or follow myositis by weeks to years. An interplay with host genetic factors, viral infection of muscle, and autoimmune mechanisms is probably contributory [3]. Deposition of immunoglobulins and the C5b-9 complement membrane attack complex has been demonstrated on intramuscular blood vessels suggesting that humorally mediated damage initiates the angiopathy that precedes muscle destruction. The final pathway for muscle fibre damage may be T-cell-dependent stimulation of B-cells, with resultant antibody-mediated cytotoxicity [4]. Whether the Immunostimulating Agent Delimmun, that our patient received for treatment of the papules on her hands, worsened the course of the Fig. 1 Gottron papules on our patient’s hand, pathognomonic for juvenile dermatomyositis Eur J Pediatr (2003) 162: 725–726 DOI 10.1007/s00431-003-1290-z