107
Participants
Start Date
May 20, 2020
Primary Completion Date
November 26, 2021
Study Completion Date
April 1, 2022
Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
"Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected.~Study Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician."
Reading Hospital, West Reading
Inova Fairfax Medical Campus, Falls Church
University of Arkansas for Medical Sciences (UAMS), Little Rock
UT Southwestern/Clements Hospital, Dallas
UTMB, Galveston
UNM Health Science Center, Albuquerque
Providence Portland Medical Center, Portland
Lead Sponsor
Terumo BCT
INDUSTRY
Marker Therapeutics AG
INDUSTRY