Q: Tell me something that makes LoneStar Heart unique.
A: We are not a typical venture capital-funded company. We have been funded privately by a very small group of wealthy individuals based in Texas. In the future, we expect to fund our growth through corporate partnerships and investments as well as the continued participation of our private investors.
Q: Talk about the technologies that originated at University of California San Francisco and led to the foundation of LoneStar Heart.
A: The original idea before LoneStar Heart was even formed was a company by the name of CardioPolymers Inc., based here in Southern California with technology from the University of California San Francisco (UCSF) and a gentleman by the name of Dr. Randall Lee, who was an electrophysiologist and professor there.
He was looking at a way to use an implantable hydrogel in combination with stem cells or growth factors. One of the shortcomings of stem cell therapies is that they don’t linger in the heart muscle very long or at all, and the effect of stem cell therapy and growth factor therapies is very, very limited and lasts for a very short time. So, nobody has really been able to show in significant clinical studies that stem cells in the heart regenerate tissue and improve long-term and permanently the condition of the failing heart.
The issue became “Can we make this better? Can we find a way for these stem cells to actually stay in the heart?” The one way to do that is to mix in these stem cells with the hydrogel.
Q: Have hydrogels been used in any other stem cell applications before?
A: Not in the heart at all. It is completely novel for the heart. As we were testing it, we found out that the hydrogel, without stem cells, had a very significant and positive effect on improving the mechanics of the heart, which led to the product that it is today: Algisyl. This product is essentially a gel that is derived from brown algae. It is extremely purified to remove all endotoxins and make it inert. It is liquid when you inject it and then it solidifies to the right degree when it is in the heart.
Normally, what you would expect is that the material will degrade after a few weeks. In our case, the material stayed put in preclinical models. After two years, the hydrogels were still there, in the same quantity and in the same position as they were in the beginning.
Suddenly, we found ourselves with a long-term, implantable device. It is a device because it has no pharmacologic or immunologic action.
Q: So how might this be useful in congestive heart failure?
A: A large majority of patients that have heart failure have a dilated, stretched out heart muscle that has a decreasing pumping efficiency and is incapable of delivering enough blood to the entire body. This is a vicious circle that continues to get worse with time and the implantable hydrogel actually stops or even reverses this negative trend. It accomplishes this by reducing the tension and the stress to the heart muscle purely through mechanical means.
Beyond this first step, to be able to achieve true regeneration of tissue and provide even greater efficacy, you will most likely have to combine a couple approaches. So, our idea has been all along to have the implantable hydrogel, which acts to mechanically improve the heart, combined with bioreactive small molecules or biologics that we have licensed from the University of Texas to provide the ability for tissue regeneration.
Q: What are you noticing in your initial studies?
A: Up to this point, we have treated a total of 11 patients — a majority of them are longer than one year out from when they received the implant. The safety, feasibility, and initial signals of efficacy look very positive. Therefore, we will soon begin a controlled randomized study in Europe to show efficacy delivering the product through surgical techniques. Later, an interventional catheter-based delivery will be added to the product mix.
We expect that in two years we will have enough data to receive approval to market in the European Union with the first version of the product.
CHI-Advancing California biomedical research and innovation