HOF Therapeutics
Whenever taxpayers are asked to foot the bill for medical innovation, they justifiably expect improved treatments, but the hype exceeds the reality. The following video is one mother's agony at the inability to help her son recover from a spinal cord injury using stem cells, a shortfall representing the majority of patient experiences. As a testament to a lack of reproducible stem cell cures, these treatments are not FDA approved in the U.S. resulting in our patients traveling to foreign counties to receive treatment. Decades into stem cell research where are the cures?
HOF Therapeutics CAP Organs are an advance directly applicable to stem cell therapies. We operate in California, where there is a state agency well-funded to support stem cell research, California Institute of Regenerative Medicine (CIRM). CIRM has funded over 200 clinical trials, and the National Institutes of Health (NIH) even more, yet no working protocol to routinely help citizens has been derived for solid tissues. Perhaps now is the time to try some other ideas, the ones CIRM hasn't funded before. such as our Cell Assembly Programmed (CAP) Organs. Further evidence of a fundamental problem is the lack of FDA approval for stem cell therapies generally. Prop 71 gave CIRM $3 billion funding, but our grant application was rejected. CIRM jumped in again during the CoVID panic in 2020 to get another $5 billion tax bond, Prop 14. Now CIRM is presenting a "public/private" model for stem cell technology, where they are financial ownership partners when grants are approved. The public was not alerted in Prop 14 to California state ambitions to run/ profit from companies in the medical space. California doesn't attempt to directly profit from its tech sectors, such as computers. Large pharma is signing up, but they seem to be mostly foreign companies that may legally outrun CIRM ownership claims. The lack of greater success in stem cell treatments may reflect flawed expenditure of public funds.
Both propositions promised California voters substantial economic benefits from stem cell therapies. They spent some of the money training students for new careers. Because the FDA hasn't approved the therapies the trainees are not earning a good living. The patients are forced to receive the therapies in foreign countries, such as Panama and Costa Rica, which are most directly receiving benefit from Californian taxpayers' investment. The good paying jobs at CIRM are given to administrators from proceeds of the bond measures that increase our sales taxes, not exactly the financial benefits promised. We are very much in favor of public expenditure to support medical research, but it is time to make changes at CIRM and the NIH. Don't blame HOF Therapeutics, we are not supported by CIRM.
An early objective of adapting human cells to tissue culture back in the 1950's was to remake tissues and organ components after growing up an expanded population. But the cells would not comply, instead they just grew as monolayers on culture dishes. Later, some researchers suspended cells in a collagen matrix that was then solidified giving the appearance of a 3D culture. Even better, epithelial cells attach and layer onto collagen, giving the appearance of an additional stratified tissue layer. This became the standard model for NIH funded projects, even though this protocol and the ingredients of most culture media, was kept secret. This created profitable businesses for Mattek and tissue culture supply companies, such as Gibco/Thermo Fisher, who sold their businesses to Swedish and English companies, which protects them from U.S. intellectual property claims. Another stage in 3D organ development has been when stem cells were found to form a 3D sphere of cells when contained in a droplet of medium, known as spheroids or organoids. The NIH funded research institutes and companies as they rushed to patent stem cell lines that expressed any markers typical of differentiated organs. These companies have had difficulty in finding uses for their patented cells, especially because the FDA hasn't approved them in patients, yet government funding created financial and academic momentum for these researchers. A recent round of NIH funded experimentation is growing out of the organoid effort where experimentation on embryonic stem cells targeting signal transduction pathways, and cytokine triggers of differentiation, is helping to map out the steps in gestation of embryos that occurs over many months in culture. In contrast, HOF Therapeutics CAP technology can use primary cells and/or stem cells in various combinations and has discovered a multi-step process that uncovers the signaling pathways required to assemble cells into complex structures with correct micro-physiology with some connection to wound healing, as occurs over days - not months. Because our method works with many cell combinations, we do not need to use patented cells. The NIH funded consortium of beneficiaries of proprietary 3D cell layering, patented cell lines, and secret cell media formulations has resisted funding CAP technology presumably because it requires disclosure of our technology that they did NOT fund, while refusing to disclose their assets developed using public tax funds. Dr. Hoeffler made a pivotal contribution in year 2000 with his scientific paper entitled "Spontaneous Cell Sorting of Fibroblasts and Keratinocytes Creates an Organotypic Human Skin Equivalent", advancing the concept of triggering cells to migrate into correct position to recreate complex physiologies. He received a U.S. patent on the technology and founded the commercial operation Xgene. We experienced major blowback in the U.S., while labs in Holland and now England have worked successfully with similar systems. Our CAP method has broader applications and has many advantages over these other systems. Some companies rely on the dominant funded paradigm believing their in house efforts to find the combination of 'special stem cells' and proprietary commercial media will enable their 3D organ efforts, or even result in successful stem cell clinical trials. Work with HOF Therapeutics instead! We can advance your programs the most at a reasonable price and under terms where you retain your property rights.