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Measuring Bladder Permeability with MRI using a Novel Contrast Agent Formulation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK108397-01
Agency Tracking Number: R41DK108397
Amount: $224,999.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA14-072
Timeline
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-20
Award End Date (Contract End Date): 2016-08-31
Small Business Information
5414 GUARINO RD
Pittsburgh, PA 15217-1919
United States
DUNS: 187190850
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JONATHAN KAUFMAN
 (412) 901-0315
 jhk@lipella.com
Business Contact
 JONATHAN KAUFMAN
Phone: (412) 894-1853
Email: jhk@lipella.com
Research Institution
 UNIVERSITY OF PITTSBURGH
 
4200 5TH AVE
PITTSBURGH, PA 15260-0001
United States

 Nonprofit College or University
Abstract

DESCRIPTION provided by applicant This project entails the development of a novel dual component MRI contrast agent formulation for the detecting permeability in the luminal surface of the urinary bladder The purpose of having such a test is ultimately to allow clinicians in certain circumstances to differentially diagnose a chronic non infectious inflammation of the urinary bladder from a pelvic floor defect The two components of the formulation permit the simultaneous tracking of the bladder wall via one component that is composed of particles having a larger particle size as well as map the local permeability of the wall via the second component composed of particles having a much smaller particle size wherein each of the two components can be tracked independently The proposed project is segmented into two aims The first aim is an animal protocol where bladder wall permeability can be chemically influenced and the second aim is a pilot clinical protocol designed to assess the feasibility of a
human diagnostic test For aim a mouse model that works well with the available bladder instillation and animal imaging equipment is proposed Protamine sulfate is the proposed drug for inducing bladder wall permeability not necessarily because it is the best model of bladder disease but because it provides the best controlled inflammatory effects in the time frames logistically available for the proposed imaging experiments Different levels of permeability induction as well as different levels of bladder distension are proposed as effectors to be tested
Since the components used in the formulation are already FDA approved for parenteral route of administration IND approval to study true cystitis in human subjects will be available This proposal thus includes aim the test of clinical feasibility in six human subjects These six human sub jects are divided into three cohorts two healthy control subjects two subjects with interstitial cystitis bladder pain syndrome IC BPS and two IC BPS subjects also having Hunnerandapos s ulcer We anticipate that the results of the both aims of this proposed Phase study will provide the foundation for the development of a subse quent Phase proposal in which we would propose the further clinical development of the formulation and diagnostic method If successful this research could ultimately lead to a product that may be helpful in diagnosing inflammatory conditions of the urinary bladder such as IC BPS a diagnostic test which has been long sought after by the urology community

PUBLIC HEALTH RELEVANCE Interstitial Cystitis Bladder Pain Syndrome IC BPS is an incurable chronic debilitating disease of the urinary bladder that involves urinary urgency frequency of urination and chronic pelvic pain Estimates of the prevalence of IC BPS in the U S range from to cases per persons Historically increased bladder permeability is suggested to be the key determinant of bladder pathology and IC BPS symptoms However there is a current lack of acceptable methods for direct measurement of bladder permeability in IC BPS patients and this proposal will develop a new objective MRI test for direct measurement of bladder permeability

* Information listed above is at the time of submission. *

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