SMS stands for Small Mobile Stem cells, discovered and named by you, Dr. Rahmo. What makes these cells unique and why do you consider them a new medical tool?
SMS cells possess distinct characteristics in terms of stability, size, shape, and specific binding abilities to crucial cells in the body, such as progenitor stem cells and mesenchymal stem cells. This interaction prompts significant biological responses, including the proliferation of these cells and the alteration of gene expression in over 1,300 genes. These capabilities underline the potential of SMS cells as a groundbreaking medical tool, establishing a novel avenue for medical research and therapy.
Initially, our focus was on diabetic wounds, where we discovered that SMS cells promote blood vessel formation. Even outside the body, SMS cells induce the formation of both microscopic and larger blood vessels, termed organoids, which remain stable for extended periods. This angiogenic ability, combined with the cells' secretion that provides a defensive mechanism against pathogens, opened up new therapeutic possibilities. These discoveries have significant implications, especially in developing treatments that can safeguard against infections and assist in tissue regeneration across various medical applications.
How do SMS cells differ from traditional stem cell therapies?
Unlike conventional stem cell therapies, which typically involve the differentiation of stem cells into specific cell types, SMS cells stimulate the body's endogenous cells to regenerate tissue. This approach ensures the regenerated tissue is fully compatible with the host, avoiding potential immunological issues associated with foreign cells. This fundamental difference underscores the unique advantage of SMS cells in promoting natural, compatible tissue regeneration, opening new pathways for treating a wide array of conditions with minimized risk of rejection. Furthermore, SMS cells exhibit very little immunogenicity which makes them ideal as an allogeneic treatment. The cells will be harvested from young, healthy adults and provided to the patients as an off-the-shelf drug.
Currently, you are focused on lung diseases, especially on COPD. What justified that approach?
With the subsidence of COVID, our attention shifted towards Chronic Obstructive Pulmonary Disease (COPD), recognizing it as a critical unmet medical need. Compelling data on the regenerative potential of SMS cells in lung tissue drove our decision. COPD, a disease-causing approximately 140,000 deaths annually in the United States and 3 million worldwide, represents a substantial global health burden, much like the scale of COVID, yet remains relatively underrecognized. Addressing such challenging and overlooked diseases aligns with our mission to tackle difficult, unmet medical needs through innovative approaches. In addition, we found that SMS cells are particularly fit for tackling lung-related diseases due to their size and stability.
Does the regenerative capability of SMS cells extend across different organs and conditions?
Yes, the regenerative effects of SMS cells can be assumed to be organ-agnostic, based on a common foundation of promoting blood vessel formation—a critical aspect of regeneration in virtually all organs. This characteristic underpins the broader applicability of these cells across a range of diseases and damages, irrespective of the specific cause. It may very well be agnostic to the cause; whether the damage stems from viral infections, bacterial infections, or environmental pollutants, the fundamental approach of regenerating the affected tissue remains consistent, highlighting the versatility and potential of SMS cells in regenerative medicine.
How do SMS cells address the challenge of engraftment in cell therapy?
Engraftment is a critical challenge in cell therapy, where many attempts fail because the cells do not properly attach to the target location. SMS cells, however, exhibit a remarkable ability to bind strongly and selectively to specific cells, significantly improving engraftment outcomes.
This characteristic was compelling in vitro, leading us to investigate their effects in animal models further. Using a small number of animals, due to ethical considerations, we were able to observe an astonishing 60% regeneration of alveoli with just a single injection. This result was even more pronounced with additional doses.
How does the unique administration method of SMS cells enhance their therapeutic potential?
One of the major hurdles in stem cell therapy is the effective administration of cells to the target organ without dispersal to unintended areas. Our approach involves directly administering SMS cells to the lungs using a nebulizer, a method that leverages the cells' small size and resilience. This strategy ensures that the cells reach the periphery of the lung efficiently, maximizing their therapeutic impact. The successful use of a mesh nebulizer in delivering SMS cells represents a significant advancement, distinguishing this therapy from other cell treatments and showcasing its potential for targeted lung therapy.
What results have been observed in animal studies using SMS cells?
For safety studies, multiple species were tested with human SMS cells, using different injection routes and for up to 4 months waiting period. No adverse reactions were detected with any of the large numbers of cells injected.
For efficacy, standard emphysema animal models of various severity were tested using multiple regimens (different doses and time intervals). The results show regeneration exceeded 60% after one dose and up to more than 100% after a second dose in 10 days or less. We expect these results to be reflected in the upcoming human studies.
What potential applications do SMS cells have for anti-aging therapies?
The remarkable efficacy of SMS cells in regenerating lung tissue opens up possibilities for treating subclinical conditions associated with aging, such as the natural loss of alveoli. This application suggests a broader use of SMS cells in anti-aging therapies, potentially offering a way to rejuvenate old lungs and improve overall lung function.
The implications of these findings extend to the military and industrial sectors as well, where the ability to treat lung damage caused by chemical exposures could have significant benefits. Our ongoing research and collaboration with military labs are exploring these applications further, highlighting the versatility of SMS cells in various therapeutic contexts.
Could you share the story behind the discovery of SMS cells?
Our discovery of SMS cells was a serendipitous outcome of research initially aimed at addressing multi-resistant tuberculosis, a significant health crisis exacerbated by HIV. In the process of exploring regenerative solutions to lung damage caused by tuberculosis, we encountered a small, rapidly moving entity in our cell cultures, initially mistaken for a bacterial contaminant. After a thorough investigation, it became evident that this entity was not a contaminant but a novel component of human cells. This realization marked an Eureka moment, confirming the presence of SMS cells across various tissues and highlighting their significant therapeutic potential.
The discovery of SMS cells in 2008 was a pivotal moment, stemming from the need to address the limitations of current stem cell therapies in terms of stability and scalability. These cells' unique stability allows for numerous passages without losing potency, a significant advancement over existing adult stem cells like mesenchymal stem cells, which lose potency after just a few passages.
Why were SMS cells not discovered earlier, given the extensive study of the human body?
The discovery of SMS cells challenges the notion that we fully understand the human body's complexities. Historically, significant discoveries have often emerged from challenging prevailing assumptions, such as the existence of organisms that can withstand extreme conditions. SMS cells eluded detection due to their unique properties, such as their resistance to conventional staining methods and their motility, which led many scientists to mistakenly identify them as contaminants. This discovery underscores the importance of curiosity and perseverance in scientific research, revealing new dimensions of human biology that were previously overlooked.
What challenges and considerations have you faced since 2008 and what has prevented you from bringing SMS cells to market thus far?
Our path to commercializing SMS cells started with establishing SMSbiotech in 2015 and has evolved to now making strategic decisions about collaboration, production, and regulatory approval. Initially considering partnerships, such as potentially working with big pharma in San Francisco for cell production, we have navigated the complexities of cell therapy development with a focus on quality and regulatory compliance. Currently, we are preparing to file for a phase 1 clinical study in Australia, attracted by the country's regulatory environment, financial incentives, and the strategic advantage of conducting initial human trials there before returning to the U.S. for broader application and compassionate use cases.
What is your investment and funding strategy for advancing SMS cells into clinical stages?
Our approach towards investment and funding has been notably conservative, focusing on gathering only the necessary resources rather than accumulating excessive capital that could lead to wasteful spending or significant dilution of ownership. We believe in utilizing funding efficiently, both to honor the value of investment in meaningful research and to protect our investors from undue dilution of their stakes. Achieving milestones with minimal investment has strategically increased the company's valuation, a balancing act that offers the potential for high rewards while acknowledging the inherent risks of running low on funds. Our backing comes from a diverse group of over 30 individual investors, including notable figures like the co-founders of Masimo Corp., who bring both financial support and industry expertise to our venture.
How do you plan to handle the scaling of SMS cell therapy, especially with upcoming clinical trials?
As we approach a pivotal phase with the first human trials imminent in Australia, the need for substantial investment and strategic partnerships becomes crucial. Our frugal approach has served us well in the early stages, but the impending clinical trials and the potential demand for SMS cell therapy necessitate a broader financial and operational base. This crucial juncture in our journey is not just about managing financial resources but also about forging collaborations that can help us scale our operations to meet the anticipated demand.
The ultimate goal transcends financial success; it is about making a profound impact on patient care, particularly for conditions like COPD, where current treatment options are severely limited. Our mission is driven by the potential to significantly improve the quality of life for millions, an ambition that could redefine treatment paradigms in regenerative medicine and beyond.
