On Wednesday, Jan. 11, viewers of KIMT News in Mason City, Iowa were introduced to a local man who is participating in a pilot research study at Mayo Clinic for his heart condition. This is a pilot study for patients diagnosed with Chronic Non-ischemic Dilated Cardiomyopathy. The study is being completed in association with Asahi Kasei Medical America and Mayo Validation Support Services, with Jeffrey Winters, M.D. serving as the principal investigator for the Department of Laboratory Medicine and Pathology at Mayo Clinic.
DLMP personnel interviewed for the story include Jeff Winters, M.D., Transfusion Medicine, and Jessica Weldon, Mayo Validation Support Services.
More About the Study
Dilated Cardiomyopathy (DCM) is a common and largely irreversible form of heart muscle disease that is the third most common cause of heart failure and the most frequent cause of heart transplantation. This pilot study is investigating the feasibility and safety of the Mysorba Immunoadsorption system. Mysorba (immunoadsorbent) consists of an adsorbing device containing a material that adsorbs/removes harmful substances including immunoglobulins from plasma in order to purify plasma. The Mysorba unit is used in combination with an extracorporeal circulation system that pumps blood and plasma through the tube sets. Mysorba removes potentially harmful substances from plasma which has been separated from the patient’s blood by the plasma separator in the system.
As the first stage, a patient’s plasma is separated from whole blood with the plasma separator (Plasmaflo OP-05W (L)). Then the second-stage Mysorba (immunoadsorbent) absorbs/removes potentially harmful substances (mainly immunoglobulin) from the plasma. Microparticles from the adsorbing device are removed by a microparticle filter. The filtered plasma is then reconstituted with the concentrated whole blood and re-infused back into the patient’s circulatory system. This is a continuous process contained within tube sets.
Mayo Clinic is the first site in the United States to be approved to participate in this study and the first site in the United States to ever complete this procedure. Patients enrolled in this study will complete a total of five Immunoadsorption procedures over a two-week period and then be followed for six months post procedures. Asahi Kasei, the study sponsor, will submit information from the first five patients who have completed the Immunoadsorption treatments to the FDA and an independent DSMB prior to enrollment of the final 15 subjects.