September 20, 2020

Made in the Cayman Islands


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regenexx_logo_rThis very interesting series of blogs about the cell therapy, called Regenexx, was found on the Investor Village website.

1 state invents, 2nd state does it, Cayman makes it = this way FDA laws are followed!
From Investor Village
Provectus Biopharmaceuticals, Inc.
I think this is a must read for life science and biotech investment leaders, whose legacy is to help bring breakthroughs into this US healthcare system.
I found it while trying to find the best stem cell treatment for a friend.
Now I wonder if that friend should go to Cayman Islands or CA!
I think Craig has enough gumption to do this same type of thing with PV10 as soon as it becomes licensed!
I wonder if Craig Dees and Co. are familiar with this company.
One state (CO) invents it, another state (CA) does it—and it is made in Cayman Islands.
Meanwhile patients are getting the treatment that the FDA has tried to stop even though the company is following FDA laws.
Gotta love it –sticking it to the FDA.
What a genius strategy this CO company is using!!
I tried to see if I can invest in it……

In fact, the FDA was initially sued by Regenerative in Denver District Court in 2008, and the case couldn’t be heard because the agency claimed that it had no formal regulatory position on what Regenerative was doing.

Stem Cells and the Lawsuit That May Shape Our Medical Future
(Image by Getty Images via @daylife
Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as drugs, in a landmark case that has far-reaching implications for the future of regenerative medicine.

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the [FDA] agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Despite the controversy, a number of clinics from coast to coast have licensed their physicians as recently as last month to provide the cell therapy, called Regenexx. This has led to renewed interest by consumers and would-be patients, and prompted the company to publish a sharply worded blog post on its website condemning the FDA’s reasoning.

The lawsuit is “concerning for every American who considers their body not to be an FDA regulated drug factory,” the blog says.

While the treatment that is the focus of the lawsuit is not used for life-threatening injuries, the company claims this case goes beyond a particular procedure to shed light on a misguided push by the FDA to establish authority over aspects of medicine never allowed it by Congress.

“We see this lawsuit as a 21st century civil rights issue that will define what control you have about the use of your own cells and tissue,” said Dr. Christopher Centeno, director of the Colorado clinic, in a telephone interview. “If a loved one is dying in intensive care and a well done study shows that the patient’s own cells can be used to help, does the patient get to decide to use those cells, or is that a decision for the FDA? Will the patient still be alive while we wait on Washington to issue this decision?”

Centeno said his company welcomed the lawsuit because they anticipated it would finally give them a chance to formally question the FDA on its policy. Since then, Regenexx has been formally supported by the American Association of Orthopedic Medicine, the Association of American Physicians & Surgeons, legal and medical experts, and an academic who testified that one of the FDA’s own medical experts who criticized the technology had a competing device.

The academic, Michael Freeman of Oregon Health Sciences University, has also faulted the FDA for its assertion that the Regenexx procedure presents a public health risk. Since the stem cells originate from the same patient into whom they are later re-injected, the treatment poses a lesser public health risk than that associated with current common medical practices and FDA-approved drugs, Freeman says in his testimony.

Regenexx works by taking a blood sample and a bone marrow sample from a patient and separating out the stem cells via centrifuge, then re-injecting those cells directly into the injured area, where they assimilate into the bone or cartilage and begin to regenerate it. Physicians for the company have shown in clinical studies cataloged at the U.S. National Library of Medicine that the therapy produces fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.

Regenerative maintains that complying with a rule that defines stem cells as drugs would impose an unbearable administrative and economic burden to the clinic and others like it, effectively stifling the industry and causing it to slow or abandon efforts to launch such treatments. Experts say that economic motivations on both sides of the debate are certainly at play.

The FDA has asked a federal judge to stop the Denver-area doctors from performing a Regenexx procedure, which involves removing stem cells from a patient’s bone marrow, expanding them in a special solution and re-injecting the cells at the site of an injury.
Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, emphasized that the FDA is suing the firm over one procedure that is not being performed in California. Ittleman said the FDA is concerned about the group’s process of adding a growth enhancer to increase the number of stem cells taken from a patient before re-implanting them. He said the California procedure does not include use of the growth enhancer.

The California treatment, he said, “has very little, if anything, to do with the procedure” that’s subject to the FDA lawsuit.

Ed Anselmo, manager of the Health Link clinic, also said the California group plans to draw tissue from patients’ bone marrow, separate the stem cells and re-inject them at the site of an injury. He said the team will not perform the procedure that involves expansion of patient cells in a solution, which is being done at a Regenexx-licensed Cayman Islands clinic. “You can’t do that in the U.S.,” Anselmo said.
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