Noninvasive cellular and acellular therapies will lead to life-extending medicines and treatments, including post-COVID anti-inflammation therapy. A new partnership between the world’s top university for biotech business incubation and Neobiosis, a global expert in regenerative medicine, may fuel a healthcare revolution.
Alachua, FLA., January 19, 2021 – The inflammation COVID-19 patients suffer during and post-COVID-19 infection (AKA “Post-COVID Syndrome”) will be one of many focuses of a new Research & Development laboratory recently launched at the University of Florida Sid Martin Innovate Biotechnology Institute, the world-recognized leader in biotechnology incubation(1). Neobiosis, which produces regenerative tissues, cells and extracellular vesicles for research and clinical trials to help the body heal itself—without surgery—will operate the laboratory at the biotech center, located in Alachua, Fla.
Neobiosis’ Founder and Chief Scientific Officer Dr. Ian White, a renowned global expert in regenerative medicine research, is behind the new R&D laboratory. “We are honored to become a part of Sid Martin,” Dr. White said. “Few researchers are chosen, and for them to choose us means the world to our organization. The resources they provide will allow us to make great strides in the field of regenerative therapy.”
Regenerative medicine has the potential to fight disease and revolutionize healthcare. The therapies center on treatments that support the body in repairing, regenerating and restoring itself. From prenatal surgical interventions to treatments for lifelong degenerative and disabling conditions, regenerative therapies can prompt the body to enact a self-healing response.
Amniotic Fluid and COVID-19
In a July 2020-published paper—titled “The Potential of Amniotic Fluid-Derived Extracellular Vesicles to Treat Severe Acute Respiratory Syndrome Coronavirus 2 Infection Versus Hydroxychloroquine in Human Patients”—Dr. White wrote about using products derived from amniotic fluid, known as “cytosomes”, to treat the inflammatory aspects experienced by patients during and post-COVID-19.
“It is agreed among scientists that [regenerative therapy] does not result in tissue regeneration by direct differentiation of transplanted cells, but rather repair is mediated by the cells through the liberation of [extracellular vesicles], which are how the cells communicate to injured tissue,” White wrote in the paper.(2) In fact, Neobiosis has a product under IND (Investigational New Drug) consideration for FDA approval which will treat said inflammatory aspects, while promoting tissue repair.
Regenerative therapy holds the promises of lasting health and wellness through FDA-approved practices. Many therapies involve amniotic fluid—the protective liquid that surrounds and nourishes an unborn baby. The fluid is discarded as medical waste following a healthy birth. However, amniotic fluid can be used to help heal damaged cells, organs or tissues.
Benefits of Regenerative Therapy Include:
- Delivering biochemical instructions and raw biomaterials to damaged tissues and organs stimulating the body’s own repair mechanisms to functionally heal previously irreparable tissues or organs.
- Modulating inflammation to facilitate recovery and tissue repair.
- Treating injuries and disease naturally without surgery and opioids.
Research will focus on therapies that involve the use of birth tissues including umbilical cord-tissue cells, amniotic fluid and Wharton’s jelly extracellular matrix, each having demonstrated huge potential within the scientific literature.
Dr. White’s work has limitless potential, but there are challenges from unreputable competitors and outdated FDA regulations. The new laboratory will use its position at the Sid Martin center to educate the public about the promise of university-supported science.
Education will help the FDA understand that current regulations have delayed the development of life-enhancing treatments. According to Dr. White, change is needed to better allow regenerative therapies to move forward at a faster pace. The current FDA approval model—a 10-to 15-year-process—is designed for Big Pharma. That same approval process does not fit biologic-therapy research. By updating the approval process, the FDA can help companies like Neobiosis continue to do things the right way, and to shut down the bad actors who don’t follow the rules.
White, officials at the University of Florida, and at Neobiosis, contend the new lab will lead to significant health breakthroughs. They also hope the university-based collaboration will help attract the best and brightest scientists to join as researchers and further the advances of this promising medical field.
“One of the advantages of being associated with the Sid Martin institute is that they offer a tremendous number of resources,” said Owen T. Carhart, co-founder and Director of Business Operations for Neobiosis. “It’s exciting to be associated with the No. 1 biotech incubator in the world. What more can one ask for?”
Speaking for the institute, Elliott Welker, Incubator Manager and Innovation NaviGator for Sid Martin Biotech said, “Sid Martin’s management chose to admit Neobiosis to our award-winning program because we saw the great opportunity and service of commercializing the next generation of cellular and acellular allogenic products for the global market. We were excited to have Dr. White and Neobiosis’ talented team join Sid Martin in their effort to develop and manufacture innovative perinatal products for research and clinical trials.”
Those involved with the new laboratory are confident their research, and connection to the University of Florida, will lead to new health treatments, expose the difference between legitimate research and non-qualified therapies, and also encourage the FDA to take a fresh look at this revolutionary field of study.
City officials also echoed this sentiment. “The City of Alachua is delighted to welcome Neobiosis to our life sciences industry ecosystem,” said City of Alachua Mayor Gib Coerper. “Sid Martin Biotech, located in Alachua, was ranked the #1 incubator in the world by the International Business Incubation Association (InBIA) for a record third time in 2020. We are excited to see Neobiosis join Sid Martin Biotech.”
Neobiosis, LLC is a contract development and manufacturing organization (CDMO) run by scientists focused on the science of regenerative medicine. The name Neobiosis means “new life”. They produce regenerative medicines from perinatal tissues, cells and extracellular vesicles (EVs) for research and clinical trials. Regenerative medicine taps into the body’s innate ability to heal itself relieving pain without opioids, being more cost effective and safer. Neobiosis is an FDA-registered CDMO operating under current Good Manufacturing Practice (cGMP) standards with cleanroom laboratories located in Alachua and Gainesville. Visit https://neobiosis.com/
2. White, Ian A.; “The Potential of Amniotic Fluid-Derived Extracellular Vesicles to Treat Severe Acute Respiratory Syndrome Coronavirus 2 Infection Versus Hydroxychloroquine in Human Patients”; 29 July 2020; Epidemiology Open Journal; Epidemiol Open J. 2020; 5(1): 8-12. doi: 10.17140/EPOJ-5-118