Heart-derived cells in hydrogel for cardiac regeneration

Funding Type: 
Disease Team Therapy Planning I
Grant Number: 
DR2-05401
Investigator: 
ICOC Funds Committed: 
$0
Public Abstract: 
This project seeks to develop [REDACTED], an engineered tissue product consisting of cells derived from a donor heart embedded in a biological material called a hydrogel. We are hoping to treat patients with recent heart attacks (myocardial infarction, or MI) and weak hearts. In such patients, [REDACTED] is designed to replace scar tissue with healthy working heart muscle, thereby enhancing the function of the injured heart. Post-MI patients who are left with weak scarred hearts number in the millions in the USA; best current therapy slows disease progression but does not reverse injury. Unlike existing treatments, which forestall but do not prevent the progression to overt heart failure, the proposed therapy is potentially curative. [REDACTED] will be manufactured by [REDACTED], in collaboration with [REDACTED], which makes the biomaterial of choice. We will perform extensive preclinical experiments to optimize formulation and dosing, and to demonstrate the safety and efficacy of [REDACTED], delivered by minimally-invasive injection catheter methods, in reducing scar size and improving function in pigs with post-MI dysfunction. Additional preclinical studies will establish clinical-grade product manufacturing, quality control and release criteria. The project will culminate in a clinical trial in patients with recent MI and weak hearts, to assess safety and efficacy (by quantification of myocardial scar size, function and perfusion, and quantification of major adverse cardiovascular events).
Statement of Benefit to California: 
The present project stands to benefit both the public health as well as the economy of the state of California. This project seeks to develop [REDACTED], an engineered tissue product consisting of cells derived from a donor heart embedded in a biological material called a hydrogel. We are hoping to treat patients with recent heart attacks (myocardial infarction, or MI) and weak hearts. In such patients, [REDACTED] is designed to replace scar tissue with healthy working heart muscle, thereby enhancing the function of the injured heart. Post-MI patients who are left with weak scarred hearts number in the millions in the USA, and in tens of thousands in California; best current therapy slows disease progression but does not reverse injury. Unlike existing treatments, which forestall but do not prevent the progression to overt heart failure, the proposed therapy is potentially curative. [REDACTED] will be manufactured by [REDACTED], in collaboration with [REDACTED], which makes the biomaterial of choice. We will perform extensive preclinical experiments to optimize formulation and dosing, and to demonstrate the safety and efficacy of [REDACTED], delivered by minimally-invasive injection catheter methods, in reducing scar size and improving function in pigs with post-MI dysfunction. Additional preclinical studies will establish clinical-grade product manufacturing, quality control and release criteria. The project will culminate in a clinical trial in patients with recent MI and weak hearts, to assess safety and efficacy (by quantification of myocardial scar size, function and perfusion, and quantification of major adverse cardiovascular events). The net result will be benefit to Californians both in terms of a new product that stands to decrease premature morbidity and mortality from heart disease, as well as by expanding employment and the economic tax base of two California companies.

© 2013 California Institute for Regenerative Medicine