Latest news with #stemcell
WIRED
5 days ago
- Health
- WIRED
Florida Is Now a Haven for Unproven Stem-Cell Treatments
Jul 24, 2025 6:30 AM In a measure that flouts the FDA, Florida says doctors can give unapproved stem-cell therapies for wound care, pain management, or orthopedic purposes. Photograph:Florida is the latest state to sidestep the authority of the Food and Drug Administration by allowing patients to access certain stem-cell treatments that have not been rigorously evaluated and approved. Under a new law that went into effect July 1, doctors in Florida can administer unapproved stem-cell therapies for wound care, pain management, or orthopedic purposes. The law comes amid growing support for medical freedom in the United States, an idea espoused by Health and Human Services secretary Robert F. Kennedy Jr., and it could prompt other states to follow. Supporters say the law helps protect patients, while critics argue it opens the door for physical and financial harm. 'There is interest in various states in enabling the sale of stem-cell products that have not been approved by the FDA,' says Leigh Turner, a bioethicist and professor of health, society, and behavior at the University of California, Irvine, who has been tracking the stem-cell industry. 'I think we're going to see more of that.' Last year, Utah passed a law allowing health care providers in the state to offer placental stem-cell therapies, which are often marketed for treating wounds and injuries, so long as they clearly note their unapproved status and get written informed consent from patients before administering them. And a 2017 law in Texas permits clinics and companies to offer unapproved stem-cell therapies to people with chronic or terminal diseases when conventional treatment options have been exhausted. Stem cells have been of immense interest for the past 30 years because of their ability to produce copies of themselves indefinitely and form more specialized cells in the body. Stem cells are central to human development during pregnancy and can be found in embryos, placental tissue, and umbilical cord blood, and are also produced naturally by adults, particularly in bone marrow, to allow the body to repair itself. They have been studied as treatments for a wide variety of ailments over the years, including arthritis, diabetes, heart failure, multiple sclerosis, and Parkinson's disease. But despite decades of research, stem cells have not produced the kinds of cures that scientists had hoped for. The only products the FDA has approved are blood-forming stem cells sourced from umbilical cord blood. They are used in transplants to treat patients with certain cancers and blood and autoimmune disorders who have had their own blood-forming stem cells destroyed by high doses of chemotherapy or radiation. The Florida law prohibits stem-cell therapies derived from embryos and classifies the use of embryonic stem cells as a third-degree felony. It also bans the use of cells taken from umbilical cords following abortions, although it allows cells to be sourced from discarded umbilical cords and placentas after live births. The FDA regulates stem cell therapies as drugs unless they are 'minimally manipulated,' meaning that any processing of the cells does not significantly alter their original relevant biological characteristics. This loophole has allowed clinics and companies to circumvent the years-long drug approval process and offer treatments of stem cells that have not been thoroughly tested for safety and efficacy. The Florida law does not specify whether stem cells offered in the state must be minimally manipulated, presumably allowing cells that are manipulated beyond that standard. Stem cells are already big business in Florida. In a 2021 study, Turner identified nearly 2,800 clinics in the US selling purported stem-cell treatments, a significant increase from the 570 clinics that he and a coauthor recorded when conducting a study five years before. In the more recent study, California, Texas, and Florida led the nation in terms of numbers of clinics. In recent years, the FDA has warned consumers about the risks of unapproved stem-cell products and issued warning letters to businesses marketing them. In 2018, President Donald Trump's then FDA head Scott Gottlieb sought to permanently shut down two stem-cell clinics, one of them in Florida, citing 'serious and permanent harm' they caused. At the Florida clinic, three patients were blinded after receiving eye injections of stem cells for age-related macular degeneration. The clinic charged $5,000 for the injections and sourced the stem cells from the patients' own fat tissue. However, Trump's new health leadership is expected to take a different approach from what was seen during the president's first term. Secretary Kennedy has been a proponent of stem cells and said on a recent podcast that he received an unproven stem-cell therapy at a clinic in Antigua for his vocal condition. He has also promised to end what he sees as the FDA's suppression of stem-cell therapies. With Kennedy overseeing the FDA, the new Florida law will likely go unchallenged for the foreseeable future. Sean Morrison, a stem-cell biologist and chair of the International Society for Stem Cell Research's public policy committee, says there is 'no chance' the Florida law will help people. 'The premise of the law is that there are stem-cell therapies that are effective for the treatment of things like orthopedic conditions that have not been approved by the FDA. That's not true. What we do know is that there are hundreds of companies in the United States, including Florida, that are selling fake stem-cell therapies,' he says, referring to products that are likely to have little or no effect on the condition they're marketed to treat. At worst, these products can cause serious complications. Morrison points to the case of Liveyon, a company that marketed its cord-blood-derived stem cells for autoimmune disorders, Alzheimer's, Parkinson's, and lung and heart diseases. In 2018, the FDA received several reports of patients needing hospitalization for bacterial infections after receiving stem-cell injections manufactured by an associated company and distributed by Liveyon. The Department of Justice brought a lawsuit against Liveyon's founder and CEO, John Kosolcharoen, claiming the company's advertising for a series of products contained multiple false and misleading statements. Kosolcharoen pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. Supporters of the Florida law, however, say it will establish guardrails for the industry and make stem-cell therapies safer for patients. 'Florida law will now require that these procedures be delivered with transparency, scientific rigor, and patient protections with informed consent through their physician,' Florida state representative James Buchanan, who sponsored the bill, said in a June 26 Facebook post. 'This legislation will positively impact the medical and tourism industries as this State becomes a hub for regenerative medicine,' he said. The law also sets certain standards for stem-cell manufacturing. Stem cells used in these therapies must be retrieved, manufactured, and stored in a facility that is registered and regulated by the FDA. Facilities must also comply with the FDA's so-called good manufacturing practices, which ensures that drugs are consistently produced with certain quality standards. In addition, physicians must obtain patient informed consent prior to administering treatments authorized under the Florida law. 'This law is providing responsible, domestic access,' says George Shapiro, chief medical officer at ZEO ScientifiX, a South Florida company that supplies stem cells. 'There are a lot of patients who currently travel outside the US to get this for pain, for inflammation, and for wound care. Now, they're able to get it here.' Turner says these measures could potentially root out some of the worst actors in the space, depending on how strictly Florida chooses to enforce the law and whether it will levy any disciplinary action or criminal penalties against businesses that don't comply with the law. But he still worries about the risks that unproven stem cells pose to patients. 'There are a lot of problems that can flow from a marketplace like this and from legislation that essentially operates as an enabler,' he says. 'People do get harmed. People do get scammed.'
Medscape
7 days ago
- Health
- Medscape
ADA 2025: Progress in Managing Type 1 Diabetes
This transcript has been edited for clarity. The one study that my patients with type 1 diabetes asked me about from the American Diabetes Association meetings was the Vertex study, where stem cell-derived islet cells were given to individuals with type 1 diabetes and followed for a year. They reported on 12 participants, and basically, these little islet cells worked. The problem, of course — and the reason I had to disappoint my patients — is that it didn't work without immunosuppression. These patients required immunosuppression, but in the setting of immunosuppression, the little new islet cells worked. We saw an increase in C-peptide production. Most patients got off of insulin. The patients had no further episodes of severe hypoglycemia, and the patients really were cured, in essence, of their type 1 diabetes — at least the small number of people followed for a year. The downside, of course, is the immunosuppression, and that's where the side effects occurred. I think this was really interesting because it's certainly proof of concept that we can take stem cells, make islet cells, and infuse them into people and have them work. We just have to figure out a way to do it without immunosuppression. The next study that my patients and I found interesting came from the Barbara Davis Center and was done by Dr Halis Akturk and his colleagues. It was looking at the use of semaglutide 1 mg as an adjunct to insulin in people with type 1 diabetes and obesity who are on automated insulin delivery systems. Now, in full disclosure, I do this all the time in my patients who are overweight or obese who wish to try combination therapy off-label with semaglutide, but this is the first randomized controlled trial to show the benefit. This was called the ADJUST-T1D trial. It was a double-blind study. This was a 26-week placebo-controlled study, and they enrolled 72 individuals with type 1 diabetes from four US clinics. They were randomized 1:1 to semaglutide or placebo once weekly while they continued on their usual automated insulin delivery systems. The insulin adjustments were guided by the investigators, along with the patients, looking at time in range, time below range, and other continuous glucose monitoring parameters. These individuals had to have a BMI ≥ 30 and an A1c between 7% and 10% coming into the study. These are fairly typical individuals with type 1 diabetes who are overweight, and they had a baseline A1c of 7.7%. The primary outcome was a composite one, looking at how many people achieved a time in range of > 70%, time below range of < 4%, and ≥ 5% weight loss. This composite endpoint was met in 36% of the participants in the semaglutide group, and this was highly significant compared to the placebo group. In terms of secondary outcomes, there was a reduction in A1c by 0.7% in the semaglutide group compared to 0.3% in the placebo group. Time in range improved. People lost, on average, 18 lb, and there was a reduction in total daily insulin dose. There was no diabetic ketoacidosis, but there were two episodes of severe hypoglycemia in each group. This was really proof of concept, which I think all of us who treat many people with type 1 diabetes and have been using incretin therapy have shown to be beneficial. I think the things we still need to watch for is obviously weight loss that's too fast because I don't think this is good for anybody, and the fact that people will need less insulin, so the insulin doses need to be reduced as people use these agents. Patients on these automated insulin delivery systems tend to do pretty well. I'm often adjusting the carb ratio and maybe the sensitivity depending on the pump, but I found this to be a pretty safe and effective way to do it. I think you just start lower, you go up slowly, and you make sure patients are tolerating the medication. I think patients really see benefit. What's not measured here are the nonglycemic benefits that we know are part of the use of incretin therapies, which I think is important. In my own clinic, I looked at outcomes at 2 years retrospectively, and people had still maintained the weight loss but some of the glycemic improvements waned over time. I think that just goes to show the difficulty of managing people with type 1 diabetes. I think this helps, and I think this was a really good trial. I'm very grateful to the investigators for doing this study. These two presentations highlight some of the progress in how we're thinking about dealing with type 1 diabetes. First, the notion of hopefully, someday having a cure that helps people with type 1 diabetes, having new beta cells that actually work. The second is using some of the drugs that we're now familiar with in terms of their benefits to people with type 2 diabetes in people with type 1 diabetes, and showing that it can be done safely and effectively. This has been Dr Anne Peters for Medscape. Thank you.
Medscape
18-07-2025
- Health
- Medscape
HHS Launches Stem Cell Program to Restore Brain Function
The federal government is looking for researchers who can, in 5 years, develop stem cell treatments to repair brain damage caused by stroke, neurodegeneration, and trauma. The Functional Repair of Neocortical Tissue (FRONT) program will make awards to scientists who can produce commercially viable graft tissue and develop engraftment procedures for functional brain recovery, according to a request for proposals issued by the Advanced Research Projects Agency for Health, which is part of the US Department of Health and Human Services (HHS). The program will specifically target the largest region in the brain, the neocortex, which is responsible for higher cognitive functioning, including attention, thought, perception, and episodic memory. Officials said the aim is to develop technology to repair damage to this part of the brain caused by stroke, head trauma, or other neurodegenerative conditions. 'No technology exists to repair damaged tissue and fully restore lost function,' FRONT Program Manager Jean Hebert, PhD, said in a statement. 'This will enable millions of individuals with what is currently considered permanent brain damage to regain lost functions, such as motor control, vision, and speech.' However, the goal of developing this technology in 5 years is 'very, very ambitious,' Brent E. Masel, MD, national medical director for the Brain Injury Association of America and clinical professor of neurology at the University of Texas Medical Branch, Galveston, Texas, told Medscape Medical News . 'It's the proverbial moon shot,' he said. 'It's going to take more than 4 or 5 years to get this accomplished.' Notably, there is no mention in the HHS announcement or the request for proposals of how much money could be awarded to researchers. Projects funded through the FRONT program will use only adult-derived dedifferentiated stem cells. Proposals that call for the use of human embryonic or fetal tissue or human-animal chimeric tissue will not be accepted, according to the solicitation. The restrictions on the types of stem cells to be considered should not be a hurdle, said Masel. 'Fifteen years ago, that would have been a limitation,' he said, adding that many researchers now work with adult-derived dedifferentiated cells. Some researchers are making strides using stem cells in brain diseases. As reported by Medscape Medical News in April, a group in Tokyo, Japan, and another group at Memorial Sloan Kettering Cancer Center, New York City, both reported positive results in early studies of using stem cells to produce dopamine in the brains of patients with Parkinson's disease. In May 2024, Stanford University, Stanford, California, researchers reported at the American Academy of Neurological Surgery that a small number of stroke patients who received neural stem cell transplants had recovered some motor function. Researchers interested in the FRONT program have until August 18 to submit a proposal summary. Final proposals are due by September 25. Masel reported that he is employed by a chain of for-profit brain injury rehabilitation facilities.
Associated Press
13-07-2025
- Health
- Associated Press
Lydian Announces Non-Invasive Orthopedic Stem Cell Treatments In Guro, Seoul
Lydian Cosmetic Surgery Clinic announces its autologous stem cell treatments in Guro district, offering non-surgical internal medicine therapies for joint pain and other chronic conditions under Dr. Abraham An's supervision at their Ministry-approved Gangnam facility. Seoul, Korea, Republic of, July 13, 2025 -- The Lydian Cosmetic Surgery Clinic in Gangnam, Seoul, has announced its autologous stem cell treatments for orthopedic applications—all supervised by Dr. Abraham An, the clinic's head physician. For more information, visit These treatments address chronic conditions such as joint pain and age-related degeneration of the joints, tendons, ligaments, and other tissues. Lydian has conducted stem cell research since 2005 and holds Ministry of Health and Welfare approval as an advanced regenerative medicine institution. This official recognition places the clinic among select facilities authorized to perform advanced regenerative procedures in South Korea. The clinic's autologous approach uses cells from the patient's own body, reducing rejection possibilities. Lydian extracts stem cells through three methods—from blood, bone marrow, and fat tissues—allowing for personalized treatment protocols based on specific patient requirements. This multi-source extraction capability represents a significant advancement over single-source methods. Safety remains paramount at the facility, which maintains a Class sterile room with 10,000-level cleanliness standards to prevent contamination during cell processing. This controlled environment preserves cell quality before reinjection. The clinic's commitment to sterile processing helps ensure the integrity of the extracted stem cells throughout the treatment process. The non-surgical injection method differs from surgical stem cell treatments that require incisions and carry higher complication risks. Lydian's process involves extracting cells, processing them under controlled conditions, and administering them through targeted injections. This approach typically results in shorter recovery times compared to surgical alternatives, a critical factor for those with limited mobility due to orthopedic problems. The clinic's research background spans nearly two decades, during which they have refined their stem cell extraction and processing techniques. This long-term research focus has enabled the development of specialized protocols for various internal medicine applications, particularly for chronic conditions that may benefit from regenerative approaches. Located at 836 Nonhyeon-ro in Sinsa-dong, Gangnam, the clinic welcomes patients from the Guro district interested in these specialized treatments. To learn more about Lydian Cosmetic Surgery Clinic's orthopedic stem cell treatments, visit Contact Info: Name: Dr. Abraham An Email: Send Email Organization: Lydian Cosmetic Surgery Clinic Address: 836 Nonhyeon-ro, Sinsa-dong, Gangnam, Seoul, Seoul 06025, Korea, Republic of Phone: +82-10-9692-5508 Website: Release ID: 89164570 In the event of detecting errors, concerns, or irregularities in the content shared in this press release that require attention or if there is a need for a press release takedown, we kindly request that you inform us promptly by contacting [email protected] (it is important to note that this email is the authorized channel for such matters, sending multiple emails to multiple addresses does not necessarily help expedite your request). Our dedicated team will promptly address your feedback within 8 hours and take necessary actions to resolve any identified issues diligently or guide you through the removal process. Providing accurate and dependable information is our utmost priority.
Yahoo
13-07-2025
- Entertainment
- Yahoo
Goldberg Reveals Specific Treatment That's Allowing Him To Have One Last Match
Goldberg will enter the squared circle one more time next month to face Gunther at WWE Saturday Night's Main Event. But at 58 years old, how is he pulling this off? WWE Hall of Famer Goldberg was a recent guest on Carcast. When asked about his training regime heading into his final match, Goldberg revealed that this match with Gunther wouldn't be possible without stem cell treatments. Advertisement 'I've worked my ass off since January. Actually, since February. I planned it out, I did the stem cells, I knew I had a number of weeks off. Let's be perfectly honest, if a Bioxcellerator didn't hook me up with the stem cells, I don't think I'd be able to be doing this,' Goldberg admitted. 'That was something that I strategically needed to place at the beginning so I could chill before slowly getting back into training and getting my shoulder back and hopefully getting my knee back and keeping my spine aligned. 'There's a lot that goes into it and I've got to be a human being along the way. I have a life to live and I have a family and I have responsibilities. There's a lot of things you've got to do at one time and again, I don't have anybody helping anymore. I've got my agents, but I don't have assistants and I don't have anybody working under the roof other than myself. It'll be a lull after this match because I won't be wrestling anymore.' [H/T: Fightful] READ MORE: Goldberg: Bully Ray Can Bite Me What do you make of Goldberg's comments? Are you excited to see him step into the ring one last time next month? Let us know your thoughts by sounding off in the comments section below. The post Goldberg Reveals Specific Treatment That's Allowing Him To Have One Last Match appeared first on Wrestlezone.
