Treating COVID-19: BioXcellerator Granted Regulatory Approval for Major Clinical Trial on Stem Cell
Leading U.S-based stem cell research and treatment company begins clinical trial -- similar to one just approved by the FDA and first such study ever approved by Colombian government healthcare regulator
PHOENIX, Oct. 14, 2020 /PRNewswire/ -- BioXcellerator, a world-leading stem cell therapy organization, announced that it is now launching a clinical trial on stem cell therapy as a treatment for acute symptoms of COVID-19.
This new research study is similar to one the U.S. Food and Drug Administration (FDA) approved at the University of Miami and is the first of its kind ever granted regulatory approval by INVIMA, the Colombian governmental regulatory agency that oversees healthcare.
That agency approved the clinical trial on (Oct. 5, 2020), the first time it has approved such research to study regenerative medicine, which is rapidly gaining the interest of scientists and physicians worldwide. The study will measure the effectiveness of using mesenchymal stem cells (MSC) to treat severe cases of COVID-19, which can often become serious and life-threatening without quick intervention.
According to Arizona based BioXcellerator, their Chief Medical Officer, Dr. Karolynn Halpert, this study creates an exceptional opportunity to research the effectiveness of regenerative medicine in treating COVID-19 and other diseases and disorders.
"While the FDA recently approved a similar study to be conducted at the University of Miami and the FDA allows stem cell therapy under its 'compassionate use' standard, that study is to determine safety. Our study is designed to evaluate both safety and effectiveness," she said.
"Existing research in the U.S. and around the world indicates that stem cells might be used to modulate a patient's immune system to treat severe acute respiratory distress syndrome (ARDS) that often develops in COVID-19 patients," she added.
Potential therapy for cases with mortality rates as high as 40%
"For most COVID-19 patients, symptoms may either be minor or even unnoticed, but roughly 1 out of 20 patients don't respond to standard treatments rapidly develop ARDS. When that happens, patients are admitted to ICUs and put on respirators," she said. "That's because the coronavirus can cause severe inflammation that damages the lungs and other organs, and unfortunately can be fatal in up to 40% of such cases."
Dr. Halpert explained that this severe inflammation develops because as the body tries to fight infection, too many cytokine molecules can be generated.
"While cytokine release is a normal immune system response, it must be modulated. Otherwise a 'cytokine storm' may result. Not only can that be fatal, it can cause lasting damage to patients who do survive," she added. "That's why it's essential that we initiate more phase one studies to find therapies which are quick and effective. And we're pleased to be taking a leadership role in the first cellular study ever approved in Colombia in partnership with our colleagues at Clinica Somer."
Three million cases and growing: Treating serious inflammation
Dr. Halpert leads a team of medical practitioners and scientists who have been working with and studying stem cell therapy for more than 10 years.
"Prior research suggests that introducing mesenchymal stem cells into the body modulates the immune system," Dr. Halpert said. "With the help of these cells, this immunomodulatory effect can save lives and prevent additional organ damage."
"With more than three million COVID-19 cases reported worldwide, quick treatment can prevent healthcare facilities from being overwhelmed with seriously ill patients," she added.
According to Dr. Halpert:
· Mesenchymal stem cells have shown great immunomodulatory effects, and are used to treat other inflammatory conditions as autoimmune and chronic inflammatory diseases.
· This therapy has already been established as safe and preliminary results indicate a positive improvement in health
· A major advantage of MSC treatment is that it can reduce harmful levels of IL-1, IL-6, and tumor necrosis factor, while increasing beneficial levels of IL-10 – yet don't express Major Histocompatibility Complex, reducing the risk of host immune reaction.
Given the potential benefits of these immunomodulatory effects, the research team is now recruiting patients for randomized trials. The study is listed at clinicaltrials.gov "Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19."
Additional research underway
"This regulatory approval represents a key milestone," according to BioXcellerator CEO Eric Stoffers. "We've been global innovators in stem cell treatments for celebrities and professional athletes for several years – now we are proud to be a part of a worldwide consortium of leading researchers and practitioners helping combat the global pandemic."
"This clinical trial is just a first step. We have more proposed studies at various levels of approval status by regulators around the world," he explained. "As I see it, getting regulatory approval from INVIMA can be more difficult than from the U.S. Food and Drug Administration (FDA), so I expect more such studies to begin soon."
"Stem cell therapy demonstrates exceptional promise in treating disease, healing injuries, extending lives, and optimizing health," he added. "Not only can this research save lives now, I'm looking forward to learning more about how regenerative medicine can extend our lives and vitality."
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About BioXcellerator: BioXcellerator, is the world leader in stem cell therapy and innovation with a record for successfully treating patients for sports and orthopedic injuries and curing debilitating diseases.