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

Related Links:

Authors: Voulgaris A, Nena E, Steiropoulos P PMID: 30338831 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Pintaudi B, Di Vieste G, Corrado F, Lucisano G, Giunta L, D'Anna R, Di Benedetto A Abstract OBJECTIVE: Myo-inositol supplementation prevents gestational diabetes (GDM) in women at risk and reduces insulin resistance in women with GDM. No data are available about its effect on glucose variability. The aim of this study was to evaluate the effects of a supplementation of myo-inositol on glucose variability in women with GDM. PATIENTS AND METHODS: Myo-inositol effect on glucose variability was studied in a pilot case-control study involving 12 consecutive pregnant women (median age 34 years, 25.0% insulin...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: MiR-124 down-regulation was associated with renal cancer cell OS-RC-2 invasion enhancement. Over-expression of miR-124 attenuated OS-RC-2 cell invasion by down-regulating STAT3 and MMP-9. PMID: 30338828 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: Aside from oxidative stress, LA possessed anti-inflammatory and immunomodulatory effects on EAE. LA might be a promising candidate for MS treatment. PMID: 30338822 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Investigation for TGF-β1 expression in type 2 diabetes and protective effects of TGF-β1 on osteoblasts under high glucose environment. Eur Rev Med Pharmacol Sci. 2018 Jan;22(19):6500-6506 Authors: Wang WD, Cheng BZ, Kang WB, Zheng RW, Cai YL, Wang XJ Abstract OBJECTIVE: The occurrence rate of delayed fracture healing in diabetes mellitus patients is high. Transforming growth factor β1 (TGF-β1) is an important regulatory factor in bone tissue repair and regeneration. However, TGF-β1 expression and its function in diabetic patient fracture have not been fully elucidated. PATI...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: Highly expressed FAL1 can promote proliferation and migration of endothelial cells through activating PTEN/AKT signaling pathway. PMID: 30338819 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Ding GZ, Li WS Abstract OBJECTIVE: Inflammatory reactions and imbalance of oxidant/antioxidant and protease/anti-protease are the major causes of chronic obstructive pulmonary disease. Based on the information mentioned, the expressions and significance of adiponectin (APN), D-dimer (DD), Interleukin (IL)-17, and high-sensitivity CRP (hs-CRP) in patients with acute exacerbation of chronic obstructive pulmonary disease were investigated in this study. PATIENTS AND METHODS: A total of 70 patients with chronic obstructive pulmonary disease were enrolled and divided into stable group (group A, 28 cases) an...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: Compelling experimental and human work has highlighted the close association connection between endoneurial microangiopathy and diabetic polyneuropathy. Future investigations will need to investigate the role of microvascular factors both in the periphery and the central nervous system in the pathogenesis of painful DPN. PMID: 30338814 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Research on changes in cognitive function, β-amyloid peptide and neurotrophic factor in stroke patients. Eur Rev Med Pharmacol Sci. 2018 Oct;22(19):6448-6455 Authors: Chen HG, Wang M, Jiao AH, Tang GT, Zhu W, Zou P, Li T, Cui GQ, Gong PY Abstract OBJECTIVE: To investigate the changes as well as the related mechanism in cognitive function and levels of serum β-amyloid peptide (Aβ) and brain-derived neurotrophic factor (BDNF) in stroke patients. PATIENTS AND METHODS: A total of 30 patients with acute stroke treated in our hospital from June 2015 to September 2016 were selected as strok...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: Transplantation of hUCMSCs in SCI mice can promote the polarization of M2 macrophages by reducing the expression of IL-7 in the injured site, thereby weakening the inflammatory response at the injured site, promoting the repair of the injured site and improving the motor function. PMID: 30338812 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
More News: ALS | Arthritis | Cancer | Cancer & Oncology | Cancer Vaccines | Cardiology | Chronic Obstructive Pulmonary | Diabetes | Endocrinology | Heart | Heart Disease | Legislation | Microbiology | Multiple Sclerosis | Parkinson's Disease | Rheumatology | Smallpox | Smallpox Vaccine | Stem Cell Therapy | Stem Cells | Stroke | Substance Abuse | Vaccines | Warnings