FDA goes after California stem cell doc for unapproved breast implant device

FDA

The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.

In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.

“This is not the first time the FDA has notified Dr. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. By illegally manufacturing and marketing this device, Dr. Berman is taking advantage of patients and exposing them to a broad range of unknown health risks, including not effectively preventing capsular contracture as the product claims or causing additional harm such as infection or adverse reactions with the breast implant,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The illegally marketed Pocket Protector is made of two sheets of expanded polymer bonded together by silicone rubber cement to make a pouch, and is intended to be implanted as a lining inside the breast pocket during augmentation procedures, according to the FDA release.

“The agency has never approved any implantable device for use in preventing or treating capsular contracture,” Gottlieb said in the posting. “Such a device would require premarket approval by the agency. Dr. Berman unlawfully marketed the unapproved product via a website and through promotional videos telling the public that the Pocket Protector was safe and beneficial for treating or preventing capsular contracture, even though the product has never been evaluated by the FDA for safety or efficacy for that or any use.”

The warning letter also included a recent inspection of Dr. Berman’s office, in which officers of the agency found the manufacturing site “inadequate for the manufacture of an implantable, sterile device.”

FDA investigators noted significant deviations from guidelines, including unvalidated manufacturing processes, lack of component control and a potential risk for microbial contamination.

“The warning letter requests that Dr. Berman immediately cease manufacturing and distributing the Pocket Protector,” Gottlieb wrote in the warning.

The new warning letter from the FDA isn’t the first time Dr. Berman has been under federal scrutiny.

Last year, Dr. Berman and associate Dr. Elliot Lander became the focus of a U.S. Department of Justice complaint for permanent injunction for allegedly offering unproven stem cell treatments at clinics in Southern California, according to an FDA release.

The same complaint also targeted Sunrise, Fla.-based US Stem Cell Clinic chief scientific officer Kristin Comella and co-owner Theodore Gradel for marketing similar unapproved stem cell products, according to the release.

The agency claims that Dr. Berman controls the operations of the California Stem Cell Treatment Center, the Cell Surgical Network Corporation and approximately 100 affiliates, which offered unapproved stem cell therapies. The order requested that all of the clinics “cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”

In 2017, the U.S. Marshals Service, on behalf of the FDA, seized five vials of Vaccinia Virus Vaccine (live), a vaccine reserved for individuals at high risk of small pox, such as U.S. military members. The vaccine was being mixed with a cellular product derived from fat and was being administered to cancer patients with potentially compromised immune systems, the FDA said.

Dr. Berman’s centers also offered stem-cell based products for a variety of experimental treatments for serious diseases and conditions including cancer, arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease and diabetes, according to the FDA release.

“The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use,” the FDA wrote in its notice.

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RenovaCare chairman ponies up nearly $16m for wound-healing stem cell SkinGun

RenovaCare-logoRenovaCare (Scottsdale, Ariz.) has announced an equity financing for $15.5 million from Kalen Capital Corporation, the family office of Harmel Rayat, who is the majority shareholder and chairman of RenovaCare. The equity financing increases his family office’s total equity investment in RenovaCare to over $20 million.

“Our long-term investment in RenovaCare speaks to our conviction that patients worldwide urgently need and deserve our regenerative SkinGun therapy, which sprays a patient’s own stem cells for rapid self-healing,” Rayat said in a press release. “I’m more confident than ever in our mission to replace painful and costly skin grafting surgeries with an ultra-gentle healing mist of one’s own skin cells. I believe we are in the right place, at the right time and with the right technology.”

The investment round allows the company to move forward in the regulatory approval process and clinical trial program. Rayat’s previous investment rounds allowed for pre-clinical development, product engineering and intellectual property filings.

Get the full story on our sister site, Medical Design & Outsourcing.

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Researchers reverse diabetes in mice by infusing them with blood stem cells

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BCH diabetes cell therapyResearchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine.

The researchers used cells that were pre-treated to make more of a protein, PD-L1, which is deficient in mice and people with Type I diabetes.

“There’s really a reshaping of the immune system when you inject these cells,” senior investigator Dr. Paolo Fiorina said in prepared remarks.

Get the full story at our sister site, Drug Delivery Business News.

Avrobio launches gene therapy program for Gaucher disease

Avrobio launches gene therapy program for Gaucher diseaseCambridge, Mass.-based Avrobio said today that it expanded its pipeline to include a preclinical program focused on a gene therapy for Gaucher disease.

The investigational gene therapy makes use of a patient’s blood stem cells, genetically modifying them with a fully functional copy of the faulty gene responsible for the glucosylceramide accumulation that is characteristic of Gaucher disease. Avrobio licensed the technology from Lund University’s Dr. Stefan Karlsson, but did not disclose the terms of the agreement.

Get the full story at our sister site, Drug Delivery Business News.

Study: Plants as 3D scaffolds for stem cells in biomedical implants

Study: Plants as 3D scaffolds for stem cells in biomedical implantsResearchers at the University of Wisconsin-Madison are aiming to create novel biomedical implants using 3D scaffolds made from the decellularized husks of parsley, vanilla and orchids. The team described their work in an article published in Advanced Healthcare Materials.

“Nature provides us with a tremendous reservoir of structures in plants,” lead author Gianluca Fontana said in prepared remarks. “You can pick the structure you want.”

Get the full story at our sister site, Drug Delivery Business News.

Stem cell treatment trial blinded three women. What went wrong?

An experimental treatment — which blinded three women after stem cells from abdominal fat were injected into their eyes — was advertised on a government-run clinical trial website but lacked proper safeguards, researchers reported Wednesday.

The report in the New England Journal of Medicine notes that the procedures were part of a national rise in the number of clinics harnessing stem cells from fat to treat a variety of diseases — even though many have not been proven to work. Two of the women thought they were getting treatment as part of a clinical trial because they learned about the procedure on clinicaltrials.gov, a database run by the National Library of Medicine that features thousands of studies, many of which are sanctioned by research organizations and have regulatory oversight.

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Jeffrey Goldberg, professor and chairman of ophthalmology at the Byers Eye Institute at Stanford University and co-author of the study, said the report aims to highlight the ethical implications of how clinical research is defined for the public and the dangers of poorly regulated trials.

“I would emphasize it’s a challenge and we can’t expect patients to fully vet these options,” he said. “And that’s where the ethics of the doctors and oversight of regulatory agencies need to play a role in the public health of our community.”

The women featured in the report sought treatment in 2015 for age-related macular degeneration, a common, progressive eye condition characterized by blurriness in the center field of vision. Their ages ranged from 72 to 88, the report said, and they paid $5,000 for the procedure. Each had both eyes treated at the same time, a protocol that is “both atypical and unsafe,” according to the researchers.

The report did not name the clinics involved in the study or its sponsor. Researchers said in a press release accompanying the study that the clinic is no longer performing the procedures but is still treating patients.

Clinicaltrials.gov shows the trial referenced in the article was sponsored by a stem cell company based in Sunrise, Fla., called Bioheart Inc., now known as U.S. Stem Cell. Dr. Shareen Greenbaum served as the trial’s principal investigator, according to the company’s press release. She is an ophthalmologist working at the Hollywood Eye Institute in Cooper City, Fla.

According to the journal report, clinicians used cells extracted from fat, and treated them with enzymes to obtain the stem cells. Blood was also drawn from the patient and then platelet-dense plasma was extracted. The cells were then mixed with plasma and injected into both eyes.

Within days, the three patients sought medical care for complications related to the procedure. Two patients suffered bleeding and each had retina detachments. The researchers said they are not expected to regain their sight.

The analysis said that the consent forms signed by the women did not mention a clinical trial. The patients paid for procedures “that had never been studied in a clinical trial, lacked sufficient safety data and was performed in both eyes on the same day,” the researchers wrote.

State insurance records show insurers for Greenbaum, U.S. Stem Cell and a registered nurse paid out more than $3 million in 2016 to patients harmed by stem cell procedures, although it is not clear if those patients are the same ones detailed in the study. U.S. Stem Cell said in a statement Wednesday that it could not comment on these cases but it is committed to “research and development of effective cell technologies.” The statement noted that the company has “successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions” since 2001. Greenbaum did not return calls for comment.

Stem cells have unique properties that researchers believe may hold promise for new treatments for a host of diseases such as diabetes and arthritis. These cells have the ability to change into different types of specialized cells and act as a repair system for tissues throughout the body.

Hundreds of stem cell clinics have sprung up across the nation offering therapies. But many of these medical interventions have not been vetted through federal protocols for safety and effectiveness. Because stem cells are harvested from the patient who will receive the treatment, many of these clinicians say they do not need the Food and Drug Administration’s approval, said Karen Maschke, a research scholar at the Hastings Center, a bioethics research institute.

In the journal report, the authors hypothesize the adverse effects of the treatment were caused by stem cells transforming into myofibroblasts, or cells that can lead to scarring. Enzymes used to extract the stem cells could have also contaminated the solution.

But the report said even if the treatment had caused no adverse effects, there’s little evidence showing that it would have worked.

Formal clinical trials have several safeguards to protect participants against adverse effects, said Maschke. Biomedical trials are overseen by an institutional review board that is responsible for reviewing the study’s research protocol to ensure participants are being protected. Patients are also required to sign consent forms that outline the risks associated with the experiment.

For large clinical trials, a separate oversight group called a data safety monitoring board conducts reviews throughout the trial to assess the risks and benefits of the experiment, Maschke said. Smaller and less dangerous trials rely on the research team and chief investigators to notify the IRB of any safety issues. Participants can also report their concerns to the Office for Human Research Protections within the Department of Health and Human Services.

Dr. Thomas Albini, one of the co-authors and an associate professor of clinical ophthalmology at the University of Miami, warned consumers that clinical trials with a fee should be carefully reviewed. “I’m not aware of any legitimate research, at least in ophthalmology, that is patient funded,” he said in the press release accompanying the study.

The government website recently expanded its requirements for those wishing to register clinical trials on the site. However, Maschke said she isn’t sure whether the new rules will lead to a more rigorous vetting process for prospective listings.

“It’s unclear whether or not anyone is enforcing required postings and what’s supposed to be in them,” she said.

Photo: Bigstock