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Next Generation Regenerative Therapy with Pim Enhanced Cardiac Progenitor Cells

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL137602-01
Agency Tracking Number: R41HL137602
Amount: $265,893.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-05-15
Award End Date (Contract End Date): 2019-05-14
Small Business Information
4455 FOXHOLLOW CT
San Diego, CA 92130-2429
United States
DUNS: 830075235
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARK SUSSMAN
 (619) 594-2983
 heartman4ever@icloud.com
Business Contact
 KATHLEEN BROUGHTON
Phone: (312) 768-3105
Email: broughton.sdsu@gmail.com
Research Institution
 SAN DIEGO STATE UNIVERSITY
 
5250 CAMPANILE DR
SAN DIEGO, CA 92182-1901
United States

 Nonprofit College or University
Abstract

PROJECT SUMMARY
Myocardial regenerative therapy is poised to revolutionize the way heart failure is treated but further
improvements and enhanced products are needed to make this therapy truly safe and efficacious Our
company CardioCreate Inc has pioneered the use of genetic engineering to enhance the regenerative
potential of human Cardiac Progenitor Cells CPCs intended for autologous therapeutic utilization CPCs
support myocardial repair and improve cardiac performance through reduction of scar size and increased
cardiac output Pim an endogenous constitutively activated enzyme found within CPCs is produced in
response to stress or pathologic injury in the myocardium Pim up regulation enhances cell survival through
mediating transcription cell growth proliferation survival and expansion of the CPC pool Our legacy of over a
decade of research on Pim biology culminates with demonstration of remarkable regenerative effects
mediated by adoptively transferred human Pim enhanced CPCs in rodent and swine models with significantly
improved cardiac performance relative to unmodified CPCs bone marrow stem cells and mesenchymal stem
cells Our studies with human Pim enhanced CPCs have also demonstrated the reversal of aging affects on
human CPCs such as down regulation of senescence markers increased telomere length and mitochondrial
activity and the enhancement of proliferation The technology of using autologous Pim enhanced Cardiac
Progenitor Cells CardioEnhancers represents a novel and efficacious treatment for heart failure leading to
improved health longevity and wellbeing of our society CardioEnhancers have the potential to provide a
potential treatment and cure for cardiovascular disease most specifically heart failure which is the leading
cause of death in the United States and equally affects men and women of all ethnicities and races This
proposal represents the convergent evolution of a decade of high level mechanistic biological research
coupled with entrepreneurial implementation of regenerative medicine solutions moving from the laboratory
toward clinical setting implementation In this Phase STTR proposal the focus will be to complete initial in
vitro safety profiling through a combination of oncogenicity and genotoxicity assessments necessary for FDA
mandated IND approval The Phase I goal is to generate the first battery of test results requested by the FDA
to evaluate the safety profile of CardioEnhancers The innovation of this STTR rests in the trajectory toward
implementation of next generation stem cell therapy for treatment of heart failure The significance of this
STTR will allow CardioCreate Inc to move forward as a small business towards the objectives of finding an
effective and safe therapeutic treatment for heart disease that may be used internationally providing highly
skilled manufacturing jobs to US citizens and advancing the high tech scientific achievement for our US
research community PROJECT NARRATIVE
Cardiovascular disease is one of the leading causes of death worldwide and affects both men and women of
all ethnicities and races Cardiac Progenitor Cells CPCs are naturally found in the heart and when enhanced
with Pim an endogenous constitutively activated enzyme found within CPCs enhances myocardial repair
and improved cardiac performance through scar reduction development of functional cardiac tissue and
increased cardiac output The technology of using autologous Pim enhanced Cardiac Progenitor Cells
CardioEnhancers represents a novel and efficacious treatment for heart failure leading to improved health
longevity and wellbeing of our society In order to advance to clinical use the safety profile of Pim enhanced
CPCs need to be established by rigorous preclinical testing

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

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