Ten years ago, the founders of GID were looking for a CEO. They made the connection between cell therapy, fat tissue and your background but you didn’t think you were the right person. What happened next?
I didn’t think I was a strong fit because I saw the position as requiring a significant background in cell biology, which I didn’t have. I helped the founders with early business development plans and funding efforts, and through that process, saw the potential for a cellular approach to healing, and the available pathways to therapy. The founders were able to raise seed capital and launch. I joined GID and am really happy I did.
When did you know cellular therapy would be successful?
The promise of cell therapy is that it can be used to heal in situations where we do not have any effective therapeutic solutions today. In some of our early clinical work we were able to very effectively treat severe skin contracture due to burns, close chronically open diabetic ulcers, and significantly reduce pain due to osteoarthritis. In these cases, all previous treatments using surgery or drugs had failed. The clinical responses were so compelling; that is when I knew cellular approaches to healing could be successful.
When and why did GID decide that fat is the preferred source for cellular therapy? (vs. PRP, bone marrow, umbilical)
Fat has two critically important aspects that make it the preferable tissue source for cellular therapies. First, it is the richest source of stromal progenitor cells per gram of tissue which means that enough cells can be harvested from a small tissue sample to create a therapeutic dose at point-of-care. The cells don’t need to be cultured or expanded or taken from another person to create a therapeutic dose. It is possible to get enough of the right cells to deliver therapy immediately at the point-of-care.
Secondly, a small amount of fat tissue is easily obtained using a simple lipo harvest procedure. Most people are willing to give up a small amount of fat but are less excited about giving up other possible tissues such as muscle, skin, or bone marrow, all of which have fewer stromal cells per gram of tissue than adipose. Blood doesn’t have any stromal cells so it is not a potential tissue source.
You have three engineering degrees: aerospace (BS), mechanical (MS), bioengineering (PhD). How did that come about?
I started in the direction of aerospace before getting an opportunity to pursue a master’s degree with an emphasis in robotics and controls. I was able to combine both degrees in the aerospace field working on systems with robotics and controls at Boeing. After five years, I made the choice to move to the medical field and went back to school for a Ph.D. in bioengineering. I have been working in the medical technology space ever since.
Precision driven results
What ‘aha’ moments did you have that led you to design a device that could efficiently isolate stromal cells from adipose tissue?
In the early phases of the company, I had the opportunity to work with scientists who pioneered cell separation and isolation processes. They had made leaps from tissue harvest to methods of processing to production of deliverable doses of cells. An ‘aha’ moment came after watching the entire process (tissue harvest to cellular implant injection) several times and realizing it could be significantly simplified and done consistently in a much shorter time-frame. Essentially, what was then requiring an entire tissue processing facility could be converted into a single-use, disposable device, which would be faster, more economical, and have much more consistent outcomes.
Is the technology design one of the reasons GID was able to meet study endpoints in its first randomized, controlled clinical trial?
Yes, the design allows cell processing to be done at point-of-care, rather than at a remote location. It makes the cell isolation process simple and reliable. It was the platform that allowed us to achieve significant clinical results at multiple sites in a randomized, controlled study.
What did it take to distill an entire tissue processing facility into a single-use, disposable device?
We went through six generations of design, prototyping, and development before creating a device that could perform all of our needed steps and processing. That model became our SVF-1 platform. It has since evolved into our current SVF-2 platform.
Potential cellular therapy applications
If the President of the United States called to say he heard that cellular therapy may help with respiratory conditions like COVID-19, what would you say?
Respiratory conditions like COVID-19 are severe inflammation of the lung. Mesenchymal stromal cells are directly responsive to inflammation and have immunomodulatory function. So, my answer would be unequivocally, yes. An autologous cellular approach is likely to be the most effective therapy, especially for patients who are very ill or progressing rapidly toward support on a ventilator.