Innovative Biotherapies, Inc. — Department of Health and Human Services SBIR Phase I: 400

Description

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