ROCKVILLE, MD, United States
ROCKVILLE, MD, United States

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Patent
Cellex, Inc. | Date: 2015-03-23

Provided are a culture vessel for NK cells and a method for culture of NK cells, which can provide high NK cell culture efficiency. The present invention has been completed by confirming that high NK cell culture efficiency can be achieved by a method of culturing a biological sample containing mononuclear cells in a cell culture vessel, a part or a whole of a surface of the cell culture vessel to be brought into contact with a biological sample being formed of a cycloolefin polymer, a part or a whole of the surface of the cell culture vessel to be brought into contact with a biological sample being coated with an anti-CD3 antibody and an anti-CD52 antibody.


Ramos-Casals M.,Cellex, Inc. | Brito-Zeron P.,Cellex, Inc. | Lopez-Guillermo A.,University of Barcelona | Khamashta M.A.,King's College | Bosch X.,University of Barcelona
The Lancet | Year: 2014

Haemophagocytic syndromes (haemophagocytic lymphohistiocytosis) have a wide range of causes, symptoms, and outcomes, but all lead to a hyperinflammatory response and organ damage-mainly reported in paediatric patients, but reports of adult presentation are increasing. Analysis of the genetic and molecular pathophysiology of these syndromes have improved the understanding of the crosstalk between lymphocytes and histiocytes and their regulatoty mechanisms. Clinical presentations with a broad differential diagnosis, and often life-threatening outcome, complicate the management, which might include supportive intensive care, immunosuppressive and biological treatments, or haemopoietic stem cell transplantation. Insufficient knowledge of these syndromes could contribute to poor prognosis. Early diagnosis is essential to initiate appropriate treatment and improve the quality of life and survival of patients with this challenging disorder.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.00M | Year: 2010

DESCRIPTION (provided by applicant): The studies from our Phase I SBIR (AI082728-01) demonstrated that it is feasible to develop the proposed assay, a biochemiluminescence assay that uses a novel flu virus neuraminidase substrate, for sensitive detection of influenza virus drug resistance. The assay is now being used by a federal agency for monitoring influenza virus drug resistance during the on-going swine flu pandemic. The goal of this Phase II project is to convert the surveillance test into a drug resistance test suitable for point-of-care (POC) use (e.g., in physician's offices), i.e., a test kit that is rapid (lt 15 min for sample collection to results), simple, sensitive, specific, economic, and easy-to-use. The POC drug resistance test will also have a secondary claim for influenza diagnosis. Thus, the test is a combo test with both flu diagnosis and drug resistance detection functions. Phase II activities include GMP manufacturing, preclinical and clinical studies. The data from the Phase II studies will be submitted to the FDA for clearance of the POC test for both the influenza diagnosis and flu drug resistance detection claims. PUBLIC HEALTH RELEVANCE: Widespread resistance of seasonal influenza H1N1 to Tamiflu, the most commonly used and stockpiled drug, raises serious issue about the effectiveness of Tamiflu stockpiled for pandemic influenza, and posts a challenge for physicians who treat influenza patients. A rapid and sensitive POC flu drug resistance test would promote rational use of the drug, thereby prolonging the effectiveness of a drug, and aid the physicians in making a better prescription decision. There is no such a test available. The primary objective of the proposed Phase II studies is to build on our Phase I efforts and develop a drug resistance test that is suitable for point-of-care use.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 213.34K | Year: 2016

DESCRIPTION provided by applicant A recent outbreak of carbapenem resistant Enterobacteriaceae CRE associated with contaminated duodenoscopes at the Ronald Reagan UCLA Medical Center highlights the importance of early detection of these clinically significant pathogens Coincidentally the Obama Administration released The National Action Plan to Combat Antibiotic Resistant Bacteria for which one of the steps of the action plan is to slow the emergence of resistant bacteria and prevent the spread of resistant infections Detection and identification of carbapenemase producing organisms CPO in health care centers is the first step to confining the source and preventing the potential spread of these multidrug resistant pathogens However detection of CPO in clinical laboratories is challenging as isolates may only have moderate reductions in susceptibilities to carbapenems and resistance may be mediated by other mechanisms i e chromosomal and plasmid mediated cephalosporinases or extended spectrum lactamase ESBL producers with decreased membrane permeability Molecular methods for the detection of carbapenemase genes are limited by the number of carbapenemase targets assayed in addition to other limitations The reference phenotypic method for detection of carbapenemase producing Enterobacteriaceae the Modified Hodge test suffers from a long turn around time lacks specificity and has poor sensitivity for certain types of carbapenemase enzymes i e metallo lactamase enzymes This project aims to develop a low cost easy to use essentially one manual step and rapid min assay to identify carbapenemase production in carbapenem resistant Gram negative bacteria suitable for surveillance and clinical laboratory use The proposed assay uses a luciferin derivatized lactamase substrate for detection of lactamase activity All reagents will be formulated in a master mix Reagent I such that the assay involves essentially one manual step addition of the sample to the master mix To differentiate carbapenemases from other lactamases a second master mix containing a carbapenem will be formulated Reagent II The signal of Reagent I indicates the presence or absence of lactamase while the signal ratio of Reagent II to Reagent I indicates whether the lactamase is a carbapenemase The proposed Phase I project will optimize the assay and use well characterized isolates as well as prospective clinical isolates to evaluate the assay Successful completion of this Phase I project will pave the way for a Phase II study which will involve multiple sites and substantially larger sample numbers A simple and rapid assay for detection of CPO will play a significant role in surveillance and help guide therapy and infection control measures PUBLIC HEALTH RELEVANCE A recent outbreak of carbapenem resistant Enterobacteriaceae CRE associated with contaminated duodenoscopes at the Ronald Reagan UCLA Medical Center highlights the importance of early detection of these clinically significant pathogens Detection and identification of carbapenemase producing organisms CPO in health care centers is the first step to confining the source and preventing the potential spread of these multidrug resistant pathogens The proposed project to develop a simple and rapid assay for detection of CPO if successful will play a significant role in surveillance and help guide therapy and infection control measures


Embodiments described herein relate to assay methods and kits for detecting resistance of any enzyme to its inhibitor due to functional alteration of the enzyme, comprising, conducting two or more reactions with two or more reagent mixes optionally containing substrates for the enzyme. The mixes are substantially similar, except that one contains no enzyme inhibitor whereas the others contain an enzyme inhibitor being tested for resistance. The ratio of the signal from the reaction with an inhibitor to that from a reaction without an inhibitor is used to indicate whether the enzyme is resistant to the enzyme inhibitor and also determine the susceptibility or resistance of the enzyme to various inhibitors and further identify enzyme variants. Embodiments further relate to assay methods comprising only two reactionsone conducted in a mix containing the inhibitor and the other without the inhibitor. Further included are devices for conducting such assays.


Provided are an agent for inhibition of cancer development, an agent for improvement of antibody productivity, and an agent for treatment of hepatitis. The agents have been completed by finding that cancer development is inhibited in a healthy subject by administering NK cells, and antibody productivity is improved by administering NK cells and a vaccine to a patient.


Trademark
Cellex, Inc. | Date: 2016-04-21

biological preparations comprising exosome; biological preparations comprising a therapeutic target protein-loaded exosome; biological preparations comprising exosome for use in the manufacture of pharmaceuticals; biological preparations comprising exosome for the use in the manufacture of cosmetics; diagnostic reagents used in the fields of biological, genetic engineering and pharmaceutical research; diagnostic reagents comprising exosome used in the fields of biological, genetic engineering and pharmaceutical research.


Trademark
Cellex, Inc. | Date: 2014-09-10

Medical diagnostic instruments for the analysis of body fluids.


Trademark
Cellex, Inc. | Date: 2016-09-26

Cell growth media for growing cells for scientific and research use. Cell growth media for growing cells for medical or clinical use.


Brito-Zeron P.,Cellex, Inc. | Ramos-Casals M.,Cellex, Inc. | Stone J.H.,Harvard University
Autoimmunity Reviews | Year: 2014

IgG4-related disease (IgG4-RD) is an emerging immune-mediated disease with the capability of involving essentially any organ. The epidemiology of this disease has not been explored in detail. A majority of patients reported in the literature to date are from Japan, but the condition has been described all across the world and there is no strong evidence to suggest a predilection for Asian populations. The mean age at diagnosis is approximately 60. years and there is a decided male predominance for many clinical features, with an overall male:female ratio of 8:3. A cardinal feature of IgG4-RD is single or multiple organ swelling that often raises concern for malignancy. IgG4-RD should be suspected in patients presenting with unexplained enlargement or swelling of one or more organs. Presenting features vary substantially according to the specialty to which patients present first; in addition, the disease can be diagnosed unexpectedly in pathological specimens or identified incidentally on radiology studies. Involvement of major organs is common and IgG4-RD may lead to organ failure, particularly in the pancreas, liver and biliary tree, kidneys, thyroid gland, lungs, and aorta. The diagnosis of IgG4-RD relies on the coexistence of various clinical, laboratory and histopathological findings, although none is pathognomonic by itself. © 2014 Elsevier B.V.

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