• March 24, 2009 - The US Food and Drug Administration (FDA) has approved a photopheresis system ( Cellex ) for palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) refractory to other therapies, Therakos, Inc, announced yesterday. (medscape.com)
  • Advancements in the new Therakos Cellex Photopheresis System have opened up this important treatment option to patients for whom it was previously unfeasible," Larisa J. Geskin, MD, FAAD, director of the Cutaneous Oncology and Photopheresis Unit and director of the Dermatology Residency Program at the University of Pittsburgh School of Medicine, Pennsylvania, said in a news release. (medscape.com)
  • The new features of the Therakos Cellex Photopheresis System were designed specifically to create a better treatment experience for both patients and the healthcare professionals administering the therapy," said Michael Yang, general manager of Therakos, Inc. (medscape.com)
  • We are thrilled about the FDA's decision to approve the new Therakos Cellex Photopheresis System, which will give patients suffering from painful skin lesions an important new therapeutic option. (medscape.com)
  • UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS ® CELLEX ® Photopheresis System. (nih.gov)
  • UVADEX ® is used in combination with the THERAKOS ® CELLEX ® Photopheresis System to extracorporeally treat leukocyte enriched buffy coat. (nih.gov)
  • UVADEX solution is U.S. Food and Drug Administration ( FDA )-approved for extracorporeal administration with the THERAKOS UVAR XTS ® or CELLEX Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment. (mallinckrodt.com)
  • The safety and effectiveness of THERAKOS CELLEX Photopheresis System for use in treating pediatric patients with steroid-refractory aGvHD has not been evaluated by the FDA or any international regulatory body. (mallinckrodt.com)
  • Background: The most common instruments used for extracorporeal photopheresis (ECP) treatment in the United States are the UVAR XTS and the CELLEX devices (Therakos, West Chester, PA). (wustl.edu)
  • When compared to the UVAR XTS instrument, the efficacy of the CELLEX instrument to arrest the decline in lung function in patients with chronic lung allograft dysfunction (CLAD) related to bronchiolitis obliterans (BOS) has not been previously evaluated. (wustl.edu)
  • Methods: The relative efficacy of the CELLEX vs UVAR XTS ECP instruments was assessed by comparing the difference in rates of FEV 1 decline before and after ECP treatment and survival in two series of lung allograft recipients with BOS who had been treated with these instruments. (wustl.edu)
  • Results: Similar Slope Difference values for change in rate of decline (6 months Post ECP - Pre ECP) were observed between the two cohorts (UVAR XTS: 85 ± 109 mL/month vs CELLEX: 76 ± 128 mL/month, p=0.72). (wustl.edu)
  • The previously approved Uvar XTS photopheresis system (Therakos) is thought to lower risk for infection and reinfusion errors. (medscape.com)
  • Dr. Geskin acted as a principal investigator for the new photopheresis system and is a paid consultant for Therakos. (medscape.com)
  • Use of the THERAKOS ® UVAR and UVAR XTS ® Photopheresis Systems after oral administration of methoxsalen were previously approved for the treatment of Cutaneous T-Cell Lymphoma. (nih.gov)
  • Therakos photopheresis systems are fully integrated closed systems and FDA -approved for the palliative treatment of the skin manifestations of CTCL in persons who have not been responsive to other forms of treatment. (mallinckrodt.com)
  • Cite this: FDA Approves Photopheresis System for Cutaneous T-Cell Lymphoma - Medscape - Mar 24, 2009. (medscape.com)
  • For the palliative treatment of Cutaneous T-Cell Lymphoma, Photopheresis consists of removing a portion of the patient's blood and separating the red blood cells from the white cell layer (buffy coat) by centrifugation. (nih.gov)
  • Extracorporeal photopheresis (ECP) is a leukapheresis-based therapeutic procedure that has been approved by the US Food and Drug Administration (FDA) for the treatment of advanced cutaneous T-cell lymphoma (CTCL) since 1988. (medscape.com)
  • Potential benefits of this easy-to-use, integrated, extracorporeal photopheresis (ECP) system include shorter treatment times and reduced extracorporeal blood volume, which may improve patient compliance and tolerability. (medscape.com)
  • 4, 5] Extracorporeal photopheresis may also have some use in the treatment of psoriasis, rheumatoid arthritis, multiple sclerosis, nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy, and scleromyxedema. (medscape.com)
  • Extracorporeal photopheresis (ECP) involves the collection of white blood cells (WBCs) with subsequent exposure to a photosensitizer, 8-methoxypsoralen (8-MOP), and ultraviolet A (UVA) radiation. (medscape.com)
  • There has been much speculation and research performed on the mechanism of action of extracorporeal photopheresis (ECP). (medscape.com)
  • Extracorporeal photopheresis (ECP) is a safe, well-tolerated procedure. (medscape.com)
  • 6] Compared with the second-generation UVAR XTS system, it requires a lower volume of blood and less time to complete. (medscape.com)
  • Animal studies suggest that the photopheresis may activate an immune-mediated response against the malignant T-cells. (nih.gov)