Tissue-Engineered Regeneration of Myocardium: Making New Heart Muscle

Jason Schulte Biocompatibility and Tissue Regeneration Laboratory Agneta Simionescu, Ph.D., Dan Simionescu, Ph.D.

Christopher Wright, M.D.

Clinical Need
Heart attack damages tissue and is replaced with scar tissue presence of scar tissue causes changes that lead to congestive heart failure (CHF) must replace scar to prevent or possibly reverse CHF
NORMAL INFLAMMATORY

Current gold standard is organs

CARDIOMYOPATH Y heart transplantation,

but severe shortage of donor

Prevalence of CHF is 6 million, with about 100,000 new patients likely to develop CHF each year1 $44 billion spent on CHF in 2015, expected to grow to $97 billion by 2030

Lloyd-Jones, D., et al., Heart Disease and Stroke Statistics--2009 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation, 2009. 119(3): p. e21-181.

Engineered Heart Tissue Graft for Replacement of Scar Tissue

Overall Goal:
Develop a thick, biomimetic, functional, vascularized graft for replacement or regeneration ofBIOREACTO scarred heart PATIENT R tissue CELL Develop scaffold by removing cells from animal S tissue SCAFFOLD Harvest patients own stem cells and seed on scaffold Use bioreactor to grow seeded scaffold into functional tissue-engineered graft

Engineered Heart Tissue Graft for Replacement of Scar Tissue

Chemical Cell So far, we have developed and characterized the scaffold s s

Engineered Heart Tissue Graft for Replacement of Scar Tissue

Developing bioreactor, and planning animal studies

Comparison to Current Products

Feature
Accessibility
Immunosuppressive Therapy

Heart Transplantation
Only 2,200 transplants performed annually, many more in need1, 2 Can result in complications

Tissue-Engineered Graft
Available materials, patients own cells; accessible to all patients Patient-tailored

Cost

$997,000 per transplant3

Should be less or comparable

Risk

High

Significant, but possibly lower

Heart Transplants: Statistics. The American Heart Association. Retrieved 24 February 2011. www.americanheart.org 2 Organ Procurement and Transplantation Network. U.S. Department of Health & Human Services. Retrieved 24 February 2011. http://optn.transplant.hrsa.gov/data 3 Hauboldt RH, Hanson SG. 2008 U.S. organ and tissue transplant cost estimates and discussion. Milliman Market Research. April 2008

Commercialization Plan
IP: Provisional application filed March 23, 2012; not converted to nonprovisional by CU tech transfer, assignee rights passed to inventors
Regulatory Pathway: High risk, clinical trials necessary
Phase
Additional Lab Development

Time
1 year

Cost
$30,000

Funding: NIH grants through pre-clinical studies, Angel and VC for Pre-clinical studies 2 years $250,000 subsequent phases
Clinical Trials 5-10 years $10-$40 M 8-13 years $10-$50 M License or Total start-up are both possible, dependent upon preclinical data

Clemson University Biomedical Engineering Innovation Campus

Mission
Strives to develop high-impact medical technology and devices for disease management and the transfer of this technology from the bench to bedside. www.cucubeinc.com