A win for stem cells | Washington Examiner

The stem cell industry has scored a major victory in its efforts to keep patient treatments exempt from Food and Drug Administration regulations, brushing aside the regulatory agencys concerns that the therapies are unproven and could be dangerous.

The FDA made that argument in 2018 when it sought court orders to stop the Beverly Hills and Rancho Mirage offices of the California Stem Cell Treatment Center from administering the treatments. The move was part of a yearslong FDA crackdown on clinics nationally claiming that stem cells can treat or cure conditions including orthopedic injuries, Alzheimers and Parkinsons diseases, multiple sclerosis, and erectile dysfunction.

Federal Judge Jesus G. Bernal of the U.S. District Court for the Central District of California oversaw a seven-day trial in May 2021 based on the FDAs lawsuit against CSCTC. More than a year later, on Sept. 1, Bernal issued a ruling siding with CSCTC. Bernal effectively rejected the FDA's argument that the clinics were selling unapproved drug products in the form of adipose cell mixtures, or connective tissue that is mainly composed of fat cells called adipocytes.

Industry attorneys say the FDA is likely to appeal the ruling by Bernal, who is based in Riverside, California, and was nominated to the federal bench in 2012 by then-President Barack Obama and confirmed by the Senate. But for now, it makes more difficult the agencys efforts to regulate some stem cell clinics. And it gives a green light to people seeking to use personal stem cells as part of medical treatments.

The FDAs lawsuits named as defenders CSCTCs founders, Dr. Elliot Lander and the late Dr. Mark Berman, who died in April. Lander said in a statement that Bernals ruling was a vindication of his companys scientific and medical bona fides.

We appreciate the Court's clear and unequivocal ruling, which affirms what we have been saying for 12 years: that our innovative surgical approach to personal cell therapy is safe and legal, Lander said. With this victory behind us, we look forward to refocusing our energy on our practice and harnessing life-changing stem cell treatments to support doctors and benefit patients across the country.

In a request for comment, a spokesperson for the regulatory agency said, The FDA is reviewing the courts decision and does not have further comment at this time.

Long-running battle

The FDA has long been skeptical of stem therapies. The agency also brought a similar suit against a Florida stem cell company. In 2015, at least three patients came forward stating they lost their eyesight after the material extracted by the Florida company, U.S. Stem Cell Clinic, was injected directly into their eyes to treat macular degeneration. The Florida clinic lost its suit in 2019, and its appeal request was subsequently denied.

In the case of CSCTC, the FDAs complaint said the treatments violated current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA argued that physician use of a patients own stem cells was equal to manufacturing a biological drug product that would, therefore, be subject to regulation.

CSCTC was founded in 2010 by Lander, a surgeon and board-certified urologist, and Berman, a board-certified otolaryngologist and cosmetic surgeon.

Berman returned from Japan in 2010 with technology that could isolate stem cells from a bodys fat from the bedside. After discovering the technology, Berman and Lander began to study the efficacy and safety of these cells. In 12 years, the team learned that stem cells are another source of repair cells, similar to bone marrow cells.

In 2012, the Cell Surgical Network, the research branch of CSCTC, was founded to teach these SVF technologies to qualified physicians across the globe who also sought to bring regenerative medicine into their own practices.

The approach quickly found adherents.

Laurie Hanna, an independent certified registered nurse anesthetist who worked previously with Berman, said stem cells relieved significant health problems.

I was living in pain with decreased quality of life. Over the course of 12 years, I was facing the prospect of a complete knee replacement and experienced a significant exacerbation of my chronic regional pain syndrome that was resistant to conventional medical treatment, Hanna told the Washington Examiner.

After surgery and chemotherapy for breast cancer, I developed lymphedema and chemo neuropathy. Through treatments with Cell Surgical Network, I was able to receive my own stem cells, Hanna said. My lymphedema significantly improved, neuropathy resolved, and quality of life was restored. Little did I know when I started personal cell therapy with CSN in 2010 that in 2022 stem cells would still be making me whole.

According to Lander, stem cell therapies are incredibly safe. They allow clinics to help patients by using their own bodies to heal in a way that is in harmony with nature, he added. Lander said that despite the intermission in treatments and research due to the suit, he and colleagues remain optimistic about the future of stem cell therapies.

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A win for stem cells | Washington Examiner