Researching the Safety and Effectiveness of Stem Cells to …

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A representative from CNN reached out to us recently with some questions about stem cells as a potential treatment for so-called long Covid. As they were working on their story, they learned about an interventional clinical trial BioXcellerator has designed to study stem-cell therapy as a possible treatment for Covid-19.

Yes, we are conducting a studyon the use of stem cells to treat cases of acute respiratory distress syndrome (ARDS) that can develop in many Covid-19 patients and cause even higher mortality rates.

But this was a study we designed back in January of 2020. Thats when the global pandemic was in its infancy. The medical community was squarely focused on coping with acute disease, not chronic symptoms that might linger long after a patient recovers. The word Covid was still unfamiliar to many people, and the term long Covid wasn't used until months later.

As we explained to CNN, theres a big difference between acute cases of a disease and chronic conditions that may require different treatment approaches. So such a study would need to be a different one with its own set of research criteria. We pointed out that few, if any, such studies have begun by any research organization, but that didnt reflect a lack of interest.

In fact, quite the contrary. Our medical team is hard at work evaluating just such a study because we need more research to determine whether stem-cell therapy may indeed be a safe and effective treatment for the long-term lingering impact of this disease.

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In the scientific community, clinical trials are designed to test the safety and efficacy of various treatments using strict controls to measure results. Im proud of our companys participation with leading scientists in a wide variety of studies.

To design these studies, scientists will often publish reviews of prior research to help guide the development of future research. I also take great pride in our participation in these types of reviews. Back in February, BioXcellerator Chief Medical Officer Dr. Karolynn Halpert and our epidemiologist Dr. Santiago Saldarriaga were coauthors of a review on this topic published in the Journal of Stem Cells Research Development & Therapy.

That review, Regenerative Rehabilitation for COVID 19 Sequelae, discusses thevarious disease processes that can impair lung function, prior research on regenerative rehabilitative approaches to treating patients and the potential for stem cells to improve treatment outcomes.

One major theme of this review is how controlling inflammation that results from an overactive immune response might help more patients recover lung function and promote healing of damaged tissue caused by the Covid virus.

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The study we are currently working on is based on treating acute Covid-19 using a specific type of stem cell:mesenchymal stem cells (MSCs) from the Whartons Jelly in donated umbilical cords. Many years of research haveshown the potential of this type of stem cell for reducing harmful inflammation. Earlier research demonstrates how stem cells can modulate the bodys immune response, which may help prevent the production of excess cytokines that can trigger serious inflammation and ARDS. As that journal review explains, MSCs release anti-inflammatory signals and growth factors that may help prevent cell death by reducing that serious inflammation.

And other studies not of stem cells show that reducing systemic inflammation through other treatments may reduce plasma levels of these harmful cytokines and, in turn, may prevent the onset of ARDS or help more patients recover from it.

Whats more, weve developed proprietary protocols for enhancing the potency of the stem cells we use for treatment through a process that include screening stem cells from donated umbilical cords for specific biomarkers that indicate the highest possible potency, selecting only those cells that meet strict criteria for potency and quality, and refining and purifying these cells before reproducing them into infusions of millions of high-potency stem cells for treatment.

This approach has led to treatments for a wide range of diseases and disorders where reducing inflammation and modulating the bodys immune response can be effective at promoting healing.

So back to the question CNN asked. Can stem cells be effective at treating long Covid? Obviously, it will take far more research by many organizations to reach any definitive conclusion, but the question itself demonstrates the importance of understanding that while there are differences between acute disease and chronic conditions, in some cases, results from one study can influence the direction of later studies.

Its also a reflection of how the value of all of our research may be uncertain now, but often becomes clear in the future. Indeed, as Soren Kierkegaard once pointed out, life must be lived looking forward, but it can only be understood by looking back.

Im not sure exactly what well understand when we look back at this unprecedented global pandemic, but we know far more about the role of regenerative medicine and stem-cell therapy in treating a wide range of diseases and how all of usentrepreneurs, scientists and physicians can work together to make even more discoveries to improve the quality of our lives.

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