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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Publication date: Available online 17 August 2018Source: Journal of Visceral SurgeryAuthor(s): T. Sarcher, B. Dupont, A. Alves, B. MenahemSummaryMultidisciplinary management of infra-peritoneal rectal cancer has pushed back the frontiers of sphincter preservation, without impairment of carcinological outcome. However, functional intestinal sequelae, grouping together several symptoms known under the name of anterior resection syndrome (ARS), have emerged and become an increasingly frequent concern for both patients and physicians. The pathophysiology is complex: ARS is a combination in various degrees of stool frequency, i...
Source: Journal of Visceral Surgery - Category: Surgery Source Type: research
ConclusionExploring perspectives in LARS patients resulted in the identification of potential improvements in current care pathways. Recommendations on ways to improve information provision, screening of LARS and methods to intervene in the gap of supportive care after discharge are presented. We recommend to implement these measures as QoL of patients undergoing colorectal cancer surgery may be improved.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
In this study, we compared perioperative and oncologic outcomes of patients treated with either open or robot-assisted radical cystectomy and intracorporeal neobladder at a tertiary care center.MethodsThe institutional prospective bladder cancer database was queried for “cystectomy with curative intent” and “neobladder”. All patients underwent robot-assisted radical cystectomy and intracorporeal neobladder or open radical cystectomy and orthotopic neobladder for high-grade non-muscle invasive bladder cancer or muscle invasive bladder cancer with a follow-up length ≥2 years were included. A 1:1 pr...
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
ConclusionBoth types of organ-sparing surgeries assessed in this study achieved good outcomes, in terms of the aesthetics, sexual functions, urinary functions, and HRQOL in patients, without compromising the therapeutic effects of these surgeries. However, the observed decreases in orgasmic function will need to be addressed further.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
Publication date: September 2018Source: European Journal of Surgical Oncology, Volume 44, Issue 9Author(s): Ricard Ramos, Ernest Nadal, Inma Peiró, Cristina Masuet-Aumatell, Ivan Macia, Francisco Rivas, Gabriela Rosado, Pau Rodriguez, Anna Ureña, Susana Padrones, Samantha Aso, Carlos Deniz, Arturo Navarro, Ignacio EscobarAbstractBackgroundAs nutritional status plays an important role in outcomes after surgery, this study evaluated the association between preoperative nutritional status (NS) and postoperative outcomes after major resection for lung cancer.MethodsWe identified 219 patients with a diagnosis of c...
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
ConclusionsThe EORTC-STBSG response score is applicable for determining the histopathological response to neoadjuvant ESTS treatment. However, this response does not seem to predict LRFS nor OS in locally advanced ESTS.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
Publication date: September 2018Source: European Journal of Surgical Oncology, Volume 44, Issue 9Author(s): A.J. Breugom, E. Bastiaannet, P.G. Boelens, E. Van Eycken, L.H. Iversen, A. Martling, R. Johansson, T. Evans, S. Lawton, K.M. O'Brien, H. Ortiz, R. Janciauskiene, O.M. Dekkers, H.J.T. Rutten, G.J. Liefers, V.E.P.P. Lemmens, C.J.H. van de VeldeAbstractIntroductionThe aim of this EURECCA international comparison is to compare oncologic treatment strategies and relative survival of patients with stage I–III rectal cancer between European countries.Material and methodsPopulation-based national cohort data from the ...
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
ConclusionsThis study indicates that the implementation and assurance of evidence-based quality standards has substantial positive effects on various patient-relevant outcomes in colon cancer care.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
ConclusionsIn our experience minimally invasive surgery is a valid therapeutic approach in very select patients with localized lymph-nodal recurrence of gynecological cancers, with benefits about peri and post-operative morbidities and without compromising their oncological outcome.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
We report of a case rapid onset systemic sclerosis complicated by acute renal failure and diffuse alveolar hemorrhage in a woman with stage IIB right breast cancer and elevated RNA Polymerase III IgG Ab. To our knowledge, this the first case of a patient with breast cancer associated with systemic sclerosis and pulmonary-renal syndrome.
Source: Respiratory Medicine Case Reports - Category: Respiratory Medicine Source Type: research
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