GAINESVILLE, Fla. (PRWEB)
December 06, 2021

Regenerative medicine is referred to by the U.S. Department of Health and Human Services as “the next evolution in medical treatments.”(1) While there are life-changing developments being made in this industry, regenerative medicine’s acceptance in the United States has been rather fractured and riddled with confusion among lawmakers, stakeholders, and the public. There are three main factors contributing to this: predatory “bad actors” in this industry, a constantly changing and often contradictory regulatory landscape and lawmakers unwittingly receiving guidance from the wrong people instead of the real experts.

“There are many people [in the field of regenerative medicine] that are untrained and give false credentials. Others put a lot of marketing money behind them and give false hope—that is where a lot of the animosity lies,” says Dr. Ian White, President and CSO of Neobiosis, a company that focuses on the science of regenerative medicine. “It’s a fundamental part of our job to communicate to the public, physicians, and lawmakers what regenerative medicine is and what it isn’t. We have to clearly explain how the body can heal itself, slow down symptoms of aging, and deal with acute injuries when supported by legitimate regenerative medicines.”

Regarding bad actors in the industry, Dr. White explains that the FDA had implemented a moratorium—discretionary enforcement of their guidelines—for the past three and a half years. The purpose of this moratorium was to give regenerative medicine manufacturers, sufficient time to submit an investigational new drug application (IND) with the FDA to make use of their products. That moratorium ended in June, which led to industry-wide confusion for everyone interested in the potential of regenerative medicine.

“Sadly, the untrained and unqualified bad actors took advantage of the moratorium to generate huge revenues from sales, which they then used to finance, and receive, INDs for their products from the FDA, without background checks or laboratory inspections by regulators. This further exacerbates the bad reputation regenerative medicine has received by critics,” explains Dr. White, who has behind him 20 years studying stem cells and regenerative medicine. Needless to say, this presents a challenge for companies like Neobiosis, who are trying to contribute to advancement of the field in an honest and forthright manner. “The deck is literally stacked against the legitimate, compliant companies and rewards brazen and dishonest practices”, explained White. Investors with interest in the huge potential of regenerative medicine just don’t know who to trust or how the FDA will alter regulatory guidelines, which leads to hesitancy.

The fact that so many people have been misled by supposed “experts” with megaphones (blogs, fallacious marketing, paid speaking engagements) leads to the second contributing factor to regenerative medicine’s challenges in America. Europe, along with countries like Japan and Australia are investing heavily in regenerative medicine and taking other steps to ensure its successful adoption into their healthcare system. Yet the United States is “the wealthiest developed country not adopting regenerative medicine because the narrative right now is that it is “snake oil” and “unproven”,” Dr. White observes. The problem isn’t that regenerative medicines themselves, such as perinatal products derived from amniotic fluid or cord blood cells and tissue, are ineffective or dangerous. There are countless studies, which have demonstrated both the efficacy and safety of such products. The issue is who is making these products and who is administering them. Many companies out there are jumping into the field because they see an opportunity to make a buck. They lie about their qualifications and about their products to regulators, investors and the public. However, there are companies who are qualified, have the appropriate facilities and can manufacture safe and effective products, but they are restricted by their ethical and moral obligations to work within outdated regulatory guidelines.

There is a common misconception that the companies producing these types of products are backed by billions of dollars. In reality, many of them operate on a shoestring budget. Why is this the case? White explains “it’s not the large pharmaceutical companies who are behind the growth of regenerative medicine, it’s the individual or small groups of scientists who spin out of academia and look to venture capital to finance the translation of new science into new biological medicines”. However, the FDA has yet to catch up to this idea as their regulatory playbook is adapted from the pharmaceutical industry, which does not fit biological regenerative medicines and scares off VC and prohibits the generation of capital from sales revenue to pay for research and clinical trials.

The global regenerative medicine market was valued at $5.444 billion in 2016 and is estimated to reach $39.325 billion by 2023. North America contributed the highest level of scientific work in regenerative medicine prior to 2016, but the Asia-Pacific region is predicted to have the highest growth rate looking forward to 2023.(2) “The U.S. in on the verge of losing momentum in this rapidly growing and innovative space, which will have implications in the medical workforce, on healthcare costs and lost opportunities for investors”, adds White.

The third contributing factor involves educating the public and industry regulators. Society has only just begun to comprehend regenerative medicine’s potential to help repair human tissues and organs, treat certain diseases, and allow some people to live longer than the standard of care might otherwise allow. This current lack of understanding foretells a steep learning curve in how to properly regulate these future medical advancements.

Dr. White’s primary motivator is his strong passion for innovative medicine and the desire to change people’s lives for the better. “I would like the opportunity to speak to legislators and bring together recognized leaders in regenerative medicine to modernize and overhaul regulatory guidelines to support the safe and effective progression of these new and exciting therapies”. Regenerative medicine is here to stay, the question the government should be asking is ‘how can we help legitimate biotech companies bring safe and effective treatments to market for a population who are demanding access to these medicines?’.

“The narrative is beginning to change”, says White. A development in the medical industry that may help shine a more legitimate light on regenerative medicine is the American Medical Society for Sports Medicine’s (AMSSM) positive stance on the industry. In 2019, the AMSSM Board of Directors arranged a task force consisting of sports medicine physicians, and recognized leaders in bioethics, research, and regenerative medicine clinical applications to produce a statement(3) in support of regenerative medicine. But also recognized it as a complex field, and provided information in the statement to help sports medicine physicians make responsible and informed decisions regarding this new medical advancement.(4) Regenerative medicine made a splash onto the sports medicine scene when The Bleacher Report wrote an article in 2013 about LA Lakers basketball player Kobe Bryant turning to biologics to cure a knee injury and shocking the world by resuming his basketball career full force in a fraction of the time it would have taken with traditional surgery. However, Kobe had to go all the way to Germany to get this treatment(5) as regenerative medicine was only in its beginning stages in the U.S.

One important way Dr. White hopes to contribute to the progress of regenerative medicine in the U.S. is by shifting the focus from relieving pain to treating the underlying causes of the pain instead. “Pain is just our nerves telling our body there’s something wrong, which needs fixing.” (6) He then referenced the opioid crisis, which has seen a 30% increase in overdose deaths in 2020 according to the CDC, as evidence of pain management having gone wrong in the U.S. (7)

By allowing appropriately qualified scientists to lend their expertise, the United States could come a long way in minimizing the confusion and skepticism surrounding this life-changing epoch in medicine. Dr. White’s message is simple: “Listen to the right people, the scientists and physicians in the trenches with ‘boots on the ground’; follow the trajectory of other countries; reform the regulatory guidelines and see to it that scammers can’t skirt the rules while looking to make a quick buck.”

About Neobiosis

Neobiosis, LLC is a clinical-stage contract development and manufacturing organization (CDMO) run by scientists focused on the science of regenerative medicine. 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 than many surgical alternatives. Neobiosis is an FDA-registered CDMO with R&D facilities and cleanroom laboratories operating under current Good Manufacturing Practice (cGMP) standards located in Gainesville, FL. Visit https://neobiosis.com/

1. “Wake Forest Institute for Regenerative Medicine (WFIRM): A Leader in Translating Scientific Discoveries Into Clinical Therapies”; Wake Forest School of Medicine; school.wakehealth.edu/Research/Institutes-and-Centers/Wake-Forest-Institute-for-Regenerative-Medicine

2. “Regenerative Medicine Market Size to Gain Traction of $39.32 Billion Growth Opportunities by 2023”; MENAFN; 15 November 2021; menafn.com/1103172975/Regenerative-Medicine-Market-Size-to-Gain-Traction-of-3932-Billion-Growth-Opportunities-by-2023

3. American Medical Society for Sports Medicine (AMSSM); “AMSSM Releases Position Statement on Regenerative Medicine in Sports Medicine”; News Wise; 1 November 2021; newswise.com/articles/amssm-releases-position-statement-on-regenerative-medicine-in-sports-medicine

4. Finnoff, Jonathan T. DO, Awan, Tariq M. DO, et al; “American Medical Society for Sports Medicine Position Statement: Principles for the Responsible Use of Regenerative Medicine in Sports Medicine”; Clinical Journal of Sports Medicine; Accessed 14 November 2021; journals.lww.com/cjsportsmed/Fulltext/2021/11000/American_Medical_Society_for_Sports_Medicine.10.aspx

5. Carroll, Will; “What is This Knee Treatment Kobe Bryant Goas All the Way to Germany for?”; 4 Oct. 2013; The Bleacher Report; bleacherreport.com/articles/1798763-what-is-this-knee-treatment-kobe-bryant-goes-all-the-way-to-germany-for

6. YouTube Video; Dr. Ian White; “Pain Revealed Episode 3”; Accessed 14 November 2021; youtube.com/watch?v=-xw2E5JnvSs

7. “Drug Overdose Deaths Up 30% in 2020”; CDC Centers for Disease Control and Prevention; 14 July 2021; cdc.gov/nchs/pressroom/nchs_press_releases/2021/20210714.htm