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ANN ARBOR, MI, United States

Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 323.82K | Year: 2015

DESCRIPTION provided by applicant The Selective Cytopheretic Device SCD is an extracorporeal medical device targeted to treat patients with inflammatory disease indications As patient blood passes through the SCD it comes in contact with the hemocompatible fibers inside the SCD These fibers are capable of immunomodulatory interactions with the patientandapos s over active white blood cells activated leukocytes The SCD has been used in three human clinical studies to date with positive clinical outcomes for critically ill adult patients with acte kidney injury AKI and multiorgan dysfunction MOD Long term objective to develop a process to manufacture fibers with an outer diameter OD m for use in a second generation SCD SCD with low blood fill volumes to enable the treatment of pediatric patients and critically ill adult patients with blood volume removal re strictions due to potential hemodynamic instability as well as treatment in out patient clinics via peripherally inserted central catheter PICC access which require low blood flow rates Fibers within the current SCD are made of polysulfone PSu and have an OD of m Current technology in hemodialysis fiber manufacturing is restricted to fabricating fibers with OD of between to m These fibers are far too large to be used in the SCD which would cause the blood priming volumes to be high and therefore not safe for pediatric patients and critically ill patiens In order to make the blood fill volumes andlt mL for these patients the fibers must be made m A lab at Virginia Tech will be used to manufacture fibers of the required specifications for the SCD device which will enable the rapid development of the fiber making process toward clinical translation for the SCD to save severely ill patientsandapos lives In this project the way in which the SCD works called the mechanism of action MoA will be explored by specifically looking at how white blood cells WBC interact with the fibers in the device Specific Aim by using fresh cow blood from a local slaughterhouse Production methodology for m OD fibers will be developed by finding just the right balance of polymers to change the surface of the fibers for the best interaction with WBC also tested with cow blood Specific Aim The fibers produced in Aim will be sterilized by different methods in Specific Aim and will be tested with cow blood These optimized sterilized fibers would be ready for use in a medical device to test in a preclinical large animal model to prove efficacy If they are safe and work well then the finalized devices could be used in a human clinical trial Health Related Impact The data generated from this proposal will advance the development of a critical manufacturing process for fabrica tion of PSu fibers needed to produce SCD It will also provide preclinical data for inclusion of regulatory sub missions to apply for IDE approval from the FDA to initiate clinical trials for the evaluation of SCD therapy in both acute and chronic disease indications including orphan diseases anti neutrophil cytoplasmic antibody ANCA vasculitis dermatomyositis Guillian Barre Syndrome GBS and pediatric AKI PUBLIC HEALTH RELEVANCE The Selective Cytopheretic Device SCD is a medical device applied during dialysis or hemofiltration that is designed for blood to flow through it with fiber inside the device that can interact with severely ill patientandapos s blood cells in order to reset and normalize their immune system The current SCD is designed for adults with kidney disease and organ failure but cannot be used on children or other severely ill patients that canandapos t withstand and arenandapos t safe if large amounts of blood is taken out of their bodies to be used in a blood circui This proposal seeks to develop a process to make special fibers for a new smaller SCD devices specifically for these sick children and critically sick patients called a second generatio SCD SCD


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 588.70K | Year: 2015

DESCRIPTION provided by applicant The Problem Cardiovascular disease is the leading cause of death in the Western world In the US nearly coronary artery bypass surgeries are performed annually with an estimated of these using the technique of cardiopulmonary bypass CPB CPB patients experience complications many of which are considered to be due to the activation of leukocytes LE which can result in systemic inflammatory response syndrome SIRS The Product The Leukocyte Modulator L MOD is based on biomimetic membrane device BMD platform technology that has been shown to alter the state of systemic LE When the BMD is placed in a citrated extracorporeal blood circuit LE are transiently sequestered in the low ionized calcium environment within the BMD and released in an altered state back to the circulation The L MOD will be developed specifically to modulate the LE activation associated with CPB thereby mitigating the associated inflammatory response Innovation Previous approaches to block SIRS associated with cardiac surgery including use of pharmacologic agents operative techniques improved biocompatibility and LE depleting filters have failed to meet clinical endpoints The L MOD is the application of BMD technology to CPB associated SIRS and represents an innovative therapy option The goal of this proposal is to demonstrate efficacy of the L MOD in ameliorating the inflammatory response and the leukocyte mediated tissue damage that is associated with use of CPB during cardiac procedures Long Term Goal This proposal details the initial steps to assess the L MOD as an effective adjunct therapeutic device to be used in conjunction with current CPB clinical protocol Phase I Hypothesis L MOD therapy will effectively reduce LE activation minimizing SIRS and accompanying tissue damage resulting from CPB Specific Aim Confirm a study protocol that results in a robust CPB associated SIRS using a pig model of cardiac surgery with CPB Specific Aim Compare the SIRS and LE induced tissue damage resulting from cardiac surgery and CPB with and without including L MOD therapy using the developed model Phase II Objective Phase II will include survival studies in which the ability of LMOD to protect agains organ damage will be evaluated in recovered animals at h with an emphasis on evaluating the safety and efficacy of L MOD therapy for limiting activated innate immune system mediated tissue damage occurring in response to on pump CPB in patients undergoing cardiac surgery Commercial Opportunity The LMOD is inexpensive and easy to distribute Value will be realized in reduced health care cost from CPB complications PUBLIC HEALTH RELEVANCE The use of cardiopulmonary bypass CPB during corrective heart surgeries elicits a systemic inflammatory response syndrome SIRS that is associated with bleeding disorders and multiple organ dysfunctions in the post operative period Leukocyte activation a major component of this immune reaction contributes to the vascular dysfunction oxidative stress and organ injury resulting from leukocyte infiltration into tissues The leukocyte modulator L MOD is a biomimetic membrane device designed for use within the extracorporeal blood circuit during CPB and was developed to modulate leukocyte activation thereby mitigating this inflammatory response Clinical trials using this technology have demonstrated as much as a reduction in mortality and a faster return of lung and kidney function in patients with SIRS and multiple organ failure resulting from sepsis In this proposal pre clinical animal model of cardiac surgery with CPB will be used to assess the ability of L MOD therapy to ameliorate the inflammatory response and reduce leukocyte mediated organ injury arising from CPB surgery


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 655.21K | Year: 2015

DESCRIPTION provided by applicant Cardiovascular disease is the leading cause of mortality in the US accounting for of all deaths Chronic Heart Failure CHF is now understood to be a multi system disease process which involves not only the cardiovascular system but also the renal neuroendocrine and immune systems There is no effective therapy currently available to treat the most severe subset of CHF patients with acute decompensated HF An unconventional approach to reduce the cardiodepressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough therapy for this disorder This proposal will evaluate the efficacy of an immunomodulatory device in a canine CHF model to identify opportunities for translation to clinical applications and eventual commercialization The Product The Biomimetic Membrane Device BMD is an immunoregulating extracorporeal fiber membrane device targeted to modulate the cardiodepressant effects that are associated with CHF BMD is a platform technology focused on immunomodulation of the acute and chronic inflammation associated with acute and chronic organ dysfunction BMD polysulfone fibers selectively sequester activated systemic leukocytes as they flow through the fiber casing via an extracorporeal circuit In preliminary studies the BMDCHF has shown promising therapeutic benefit in a canine model of CHF In novation In regard to current HF therapeutic strategies the BMDCHF is a totally different innovative approach to treat CHF Rather than utilizing small pharmacologic molecules to improve myocardial contractility the BMDCHF acts as an immunomodulatory device to dampen the cardio depressant effects of the chronic pro inflammatory state of CHF Long Term Goal This proposal will provide proof of concept for impact of the BMDCHF on CHF for up to weeks post therapy Phase I Hypothesis The planned experiments will demonstrate improvement of cardiovascular performance after multiple hour BMDCHF therapy sessions in a canine model of CHF Aim Assess impact of x hour BMDCHF sessions in a canine model of CHF at hours post therapy Aim Assess BMDCHF therapy in a canine model of CHF at and weeks post therapy Phase II Objective The Phase II plan will assess BMDCHF optimal dose with respect to number and length of sessions and long term impact months of therapeutic effect on cardiovascular and inflammatory parameters in a canine model of CHF Commercial Opportunity The data generated during the course of the Phase I and II study plans will be incorporated into the pre clinical section of an IDE submission to the FDA for testing of the BMDCHF in the treatment of CHF The market for these indications exceeds $ b annually in the US alone PUBLIC HEALTH RELEVANCE The goal of this proposal is to develop an effective therapy for treatment of Chronic Heart Failure CHF The therapeutic benefit afforded by the Biomimetic Membrane Device for treatment of CHF BMDCHF is based on its ability to sequester bind leukocytes that were activated due to the chronic inflammatory state associated with CHF immunomodulate and then release these leukocytes in a now andquot resetandquot state that is more close to normal The relevance of the work in this proposal to the general public is that the BMDCHF will improve the clinical outcome of patients who suffer from CHF and therefore increase the survival rates for this disease indication


Patent
University of Michigan and Innovative Biotherapies, Inc. | Date: 2010-06-30

The present invention relates to systems and devices to treat and/or prevent inflammatory conditions within a subject and to related methods. More particularly, the invention relates to systems, devices, and related methods that sequester leukocytes and/or platelets and then inhibit their inflammatory action.


Patent
University of Michigan and Innovative Biotherapies, Inc. | Date: 2011-04-15

The present invention relates to systems and devices to treat and/or prevent inflammatory conditions within a subject and to related methods. More particularly, the invention relates to systems, devices, and related methods that sequester leukocytes and/or platelets and then inhibit their inflammatory action.

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