UNMET NEED
Heart failure after myocardial infarction (MI) is a common and morbid condition that affects millions worldwide. While there are multiple therapies that help the heart adapt and compensate for the damage incurred in an MI, there remains no method by which injured heart muscle may be repaired or replaced. Stem cell therapy shows great promise to regenerate and repair damaged heart tissue, and thereby prevent heart failure, although the effects in clinical trials to date are modest. Reasons for the modest effects include: a) current delivery methods, which result in poor retention and survival of stem cells in the heart following delivery, b) use of autologous (a patient’s own) stem cells, which often have reduced therapeutic potential, and c) a lack of focus on paracrine mechanisms, by which stem cell-secreted factors are used to “turn on and/or turn up” resident tissue repair. A novel therapeutic strategy is needed to deliver on the promise of stem cell therapy for the heart and prevent heart failure after MI.
VALUE PROPOSITION
The intravascular stem cell bioreactor is designed to address and overcome many of the current limitations of stem cell therapy for the heart. The bioreactor is an implantable device that may be deployed in the intravascular space and provides protective housing for large numbers of exogenous stem cells. Within the bioreactor stem cells are protected from washout, dilution, and immune attack, resulting in prolonged survival in the body. From the bioreactor stem cells freely release beneficial proteins, growth factors, and cytokines, a.k.a. “paracrine factors” to promote regeneration and repair of injured heart tissue.
TECHNICAL DETAILS
The bioreactor consists of a biocompatible implantable semi-permeable enclosure designed to provide protective housing for contained stem cells while allowing free release of beneficial stem cell-produced factors to the vascular space. The invention includes two classes of bioreactors, a) a catheter-based bioreactor designed for systemic delivery of beneficial factors, and b) a miniaturized bioreactor construct designed for application to stents or other intravascular devices for local delivery to the heart or peripheral vasculature.
