The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) […]
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell face creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below. The stem cell creams sold by Cell Vitals
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What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what
23andMe and the FDA: Perspectives on Warning Letter Read More »
The FDA warning letter that Celltex received in late September (but that just went public yesterday–see my initial reaction here) is a possible game-changer for that company in my opinion. Why? The letter outlined in great detail the FDA’s concerns with how Celltex manufactures its stem cell product ranging from lack of documentation to concerns about aseptic/sterile
Will stem cell clinic Celltex reinvent itself after game-changing FDA warning letter? Read More »
Sugarland, Texas stem cell clinic, Celltex, is most well known for having done the stem cell treatment on Texas Governor Rick Perry. What’s up with Celltex this week? There has a lot of talk behind the scenes that something big has happened. Very recently Celltex put out a PR recently saying it had received a
Did Celltex just get an FDA warning letter? I’m not sure. We may find out tomorrow as the FDA updates their public warning letter list early in the week. What’s Celltex? Celltex is that famous stem cell company in Sugarland, Texas that gave Guv Rick Perry stem cell transplants. It was inspected by the FDA
Did Celltex just get an FDA warning letter? Read More »
If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is
Dr Lookgood, dermatologist to the stars, gets FDA warning letter Read More »
Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the
Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters Read More »
The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start
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Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell
Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis Read More »