A study of alloHCT with Orca-Q for the treatment of primary progressive multiple sclerosis (MS).
Participants aged ≥18 and ≤65 years with primary progressive multiple sclerosis
A diagnosis of PPMS by 2017 McDonald criteria and 2013 clinical course revision102
CSF with elevated IgG index or 2 or more oligoclonal bands
EDSS (see Appendix 9) between 2.0 and 5.5 inclusive
History of Progressive Multifocal Leukoencephalopathy
Renal insufficiency as defined by an estimated GFR <60 mL/minute
Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction <50%. Participants with a history of these conditions may enroll if they are demonstrated to have optimal cardiac function (as defined by echocardiography or multi-gated acquisition scan)
Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pre-transplant pulmonary function testing demonstrating a FEV1 <70% expected and/or a DLCOadj <70% expected.
Stanford University
Lead sponsor
Orca Biosystems, Inc.
Collaborator