FDA Lays the Smackdown on Illegal Stem Cell Clinics

FDA is cracking down on stem cell clinics that market unapproved products and don't meet good manufacturing practice requirements. On behalf of the agency, the Department of Justice filed two complaints in federal court this week seeking permanent injunctions against a Florida-based clinic and a California-based clinic.  “Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products," said FDA Commissioner Scott Gottlieb, MD. The agency said Sunrise, FL-based US Stem Cell Clinic ignored the violations outlined in an August 2017 warning letter and failed to come into compliance with the law, continuing to sell unapproved stem cell products. FDA also said US Stem Cell Clinic was found to be in violation of current good manufacturing practice requirements, including some that could impact the sterility of their products and put patients at risk.  FDA also filed for a permanent injunction against Rancho Mirage, CA-based California Stem Cell Treatment Center, which also has a Beverly Hills location, and Rancho Mirage, CA-based Cell Surgical Network Corp., along with Elliot Lander, MD, and Mark Berman, MD. According to the agency's complaint, Berman and Lander control t...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Source: Lasers in Medical Science - Category: Laser Surgery Source Type: research
AbstractThe aim of this in vitro study was to evaluate the effects of low-level laser therapy (LLLT) at different energy intensities on proliferation and osteogenic differentiation of bone marrow mesenchymal stem cells (BMSCs) under healthy and inflammatory microenvironments. Human BMSCs and BMSCs from inflammatory conditions (i-BMSCs, BMSCs treated with tumor necrosis factor α; TNF-α) were subject to LLLT (Nd:YAG;1064 nm) at different intensities. We designed one control group (without irradiation) and four testing groups (irradiation at 2, 4, 8, and 16 J/cm2) for both BMSCs and i-BMSCs. Cell prolife...
Source: Lasers in Medical Science - Category: Laser Surgery Source Type: research
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Source: Lasers in Medical Science - Category: Laser Surgery Source Type: research
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