The 3D Platelet Bank: A Clinical-grade, Scalable, 3D Microbioreactor Bone Marrow Mimetic for Platelet Production Current methods for collecting, culturing and processing donor-derived platelets for immediate transfusion are inefficient, costly and associated with significant regulatory safety issues including morbidity and mortality due to transfusion reactions, infection or inefficacy. Low numbers of volunteer donors willing to undergo apheresis collection of platelets as well as the inability to store platelets longer than 5 days (as compared to 42 days for whole blood) contributes to the significant deficiency in platelet availability. Alternative donor-free sources, improved processing and storage of platelets represent a significant clinical need. In response to this significant clinical need, KIYATEC proposes to establish The 3D Platelet Bank: A Clinical-grade, Scalable, 3D Microbioreactor Bone Marrow Mimetic for Platelet Production. To this end, the company will establish a perfusion bioreactor system capable of culturing megakaryocytes (MK) in a more physiologic 3D microenvironment for the intent of producing clinically relevant quantities of platelets. Initial strategy will be to establish a highly scalable and cost-effective 3D culture system by combining the strengths of KIYATEC's bioreactor design, manufacturing and commercialization experience with Tufts University's biomaterial scaffold design and fabrication expertise. The novel merger of the two synergistic technology platforms will represent a significant game-changing leap forward in creating a donor-free platelet source as an alternative to limited donor-derived platelet volumes and throughput.

Public Health Relevance

Existing means for donor-derived platelet sourcing and storage have significant drawbacks due in part to the inability to store platelets longer than 5 days. This fact results in severe shortages or complete lack of platelet availability for therapy in underserved and remote regions. KIYATEC is working to establish an alternative donor-free platelet source by designing, building and applying a novel 3D cell culture bioreactor technology to mimic the human body?s bone marrow and stimulate the production of clinically viable platelets.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
3R43EB021704-01S1
Application #
9126782
Study Section
Special Emphasis Panel (ZHL1-CSR-O (M2))
Program Officer
Hunziker, Rosemarie
Project Start
2015-08-24
Project End
2015-11-30
Budget Start
2015-08-24
Budget End
2015-11-30
Support Year
1
Fiscal Year
2015
Total Cost
$29,260
Indirect Cost
Name
Kiyatec, LLC
Department
Type
DUNS #
607554099
City
Greenville
State
SC
Country
United States
Zip Code
29605