Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lung transplantation often develop pulmonary complications. These transplant recipients often develop a potentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), a consequence of graft versus host disease (GVHD). Early diagnosis of BOS is vital for maintaining quality of life and improving overall survival, as few treatment options exist once BOS becomes established in lung tissue. Treatments for BOS remain limited, as other pulmonary complications with similar symptoms to BOS, such as infections, are prevalent and ultimately delay diagnosis. Clinical access to the PRM technology, with its ability to simultaneously delineate specific diseases, would have an immediate and positive impact on this patient population. For this promising technology to enter routine clinical use for transplant recipients a commercial application must be developed, tested and integrated within the clinical workflow using relevant CT data and a PRM technique adapted to this patient population. In this grant effort, we propose to achieve this goal through our close partnership between University of Michigan (UM) and Imbio, LLC investigators. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRM software application, including product testing and data acquisition necessary for a FDA 510(k) application using paired CT data and HSCT and lung transplant recipient information.

Public Health Relevance

Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lung transplantation often develop pulmonary complications. These transplant recipients often develop a potentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), a consequence of graft versus host disease (GVHD). In this application, we propose to extend our FDA approved Lung Density Analysis software, which is currently used for COPD diagnosis, to aid in the early diagnosis of (BOS). This software is based on a technique called ?Parametric Response Mapping (PRM),? which has been featured in Nature Medicine as a novel CT-based technique for assessment of small airways disease. The Specific Aims of this Fast-Track proposal will develop a commercial PRM software application, including product testing and data acquisition necessary for a FDA 510(k) approved clinical application for the BOS population.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44HL140894-03
Application #
9940765
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Craig, Matt
Project Start
2018-08-01
Project End
2022-05-31
Budget Start
2020-06-01
Budget End
2021-05-31
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Imbio, LLC
Department
Type
DUNS #
078397649
City
Minneapolis
State
MN
Country
United States
Zip Code
55413