Terumo BCT Launches New Clinical Trial: Red Blood Cell Exchange in Patients with Sickle Cell Disease Using the Spectra Optia® Apheresis System

RBCX study to evaluate another treatment option for patients in the U.S. on the next-generation therapeutic apheresis platform

LAKEWOOD, Colo.--(BUSINESS WIRE)--Terumo BCT announces that it has begun a U.S. clinical trial to evaluate the Spectra Optia system’s new Red Blood Cell Exchange (RBCX) Protocol in patients with sickle cell disease. To date, the RBCX Protocol on the Spectra Optia system is available in other world areas for patients with sickle cell disease and for other conditions that require red blood cell exchange.

KEY FACTS:

• Terumo BCT is working with five U.S. hospitals to study the performance and safety of the Spectra Optia RBCX Protocol in adult and pediatric patients with sickle cell disease.
  • In patients with sickle cell disease, the abnormal hemoglobin (hemoglobin S) in the cells sticks together when oxygen is released to the tissues, causing clumping that forces red cells to become stiff and sickle shaped.
  • Patients with sickle cell disease often experience pain, fatigue and difficulty breathing, among other symptoms.
  • Sickle cell disease can lead to stroke; damage to the heart, kidneys, liver and lung tissue; anemia; and serious infections.
  • Patient enrollment began in November 2012. The study is expected to be complete by the end of 2013.
  • RBCX is one of the next protocols for which Terumo BCT will seek U.S. Food and Drug Administration (FDA) clearance for U.S. release, in an effort to support the patient population who require RBCX as part of their sickle cell disease treatment.
  • The RBCX Protocol on the Spectra Optia system is already available in Canada and in Europe.
• In the U.S. and Canada, the Spectra Optia system also offers therapeutic plasma exchange (TPE) and mononuclear cell (MNC) collection protocols.
• A total of eight protocols are available in Europe, Australia, Africa, the Middle East and select areas of Asia: TPE, MNC, RBCX, TPE with single-needle access, TPE with a secondary plasma device, granulocyte collections, and white blood cell depletions and platelet depletions.
• In addition to the Spectra Optia system, Terumo BCT continues to support its entire range of therapeutic platforms, including the COBE® Spectra Apheresis System, the Elutra® Cell Separation System and the COBE® 2991 Cell Processor.

KEY QUOTES:

Bob Sullivan, Vice President, Therapeutic Systems

“This U.S. clinical trial is a vital contribution to advancing medical knowledge, in order to improve the treatment and care of the patients our customers serve. Evaluating and advancing the RBCX Protocol underscores Terumo BCT’s commitment to developing dependable therapeutic apheresis solutions with customer insight on the next-generation Spectra Optia system. We look forward to sharing updates as this clinical trial progresses.”

KEY RESOURCES:

• Study Details on ClinicalTrials.gov
• Spectra Optia Fact Sheet

About Terumo BCT:

Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.