Spots Global Cancer Trial Database for Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
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Trial Identification
Brief Title: Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
Official Title: A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis
Study ID: NCT01684761
Study Description
Brief Summary: The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).
Detailed Description: Subjects whose myelin reactive T-cell can be identified by EPA will are randomized and provide blood to manufacture Tcelna. Approximately 5 weeks after receipt of the subject's whole blood procurement, the subjects will receive either Tcelna or placebo and will complete baseline assessments and will receive study treatments at Weeks 0, 4, 8, 12, and 24 (Visits 3-7), totaling 5 doses in year one. Approximately one month prior to the Week 52 visit a second blood procurement will be performed and the subject will receive the second series of treatments as received in the first year study schedule. Subjects will be evaluated for changes in disability and cognitive function every 3 months, and radiographic changes annually.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HOPE Research Institute, Phoenix, Arizona, United States
Northwest NeuroSpecialists, LLC, Tucson, Arizona, United States
Alta Bates Summit Medical Center, The Research and Education Development Institute, Berkeley, California, United States
Neurology Associates, P.A., Maitland, Florida, United States
University of Miami, Miami, Florida, United States
Collier Neurologic Specialists, LLC, Naples, Florida, United States
Neurological Services of Orlando, Orlando, Florida, United States
Meridien Research, Tampa, Florida, United States
Vero Beach Neurology, Vero Beach, Florida, United States
Shepherd Center, Atlanta, Georgia, United States
Consultants In Neurology, Ltd., Northbrook, Illinois, United States
Fort Wayne Neurological Center, Fort Wayne, Indiana, United States
Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Associates in Neurology, Lexington, Kentucky, United States
Saint Elizabeth's Medical Center, Boston, Massachusetts, United States
Island Neurological Assoicates, PC, Plainview, New York, United States
University Hospital and Medical Center Stony Brook New York, Stony Brook, New York, United States
The Neurological Institute, PA, Charlotte, North Carolina, United States
Carolinas Medical Center Neurology, Charlotte, North Carolina, United States
PMG Research of Charlotte, Charlotte, North Carolina, United States
Neurology Specialists, Inc, Dayton, Ohio, United States
Providence Medical Group - Medford, Medford, Oregon, United States
Providence St. Vincent Medical Center - Northwest MS Center, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The Maxine Mesinger MS Clinic/Baylor College of Medicine, Houston, Texas, United States
Central Texas Neurology, Round Rock, Texas, United States
Integra Clinical Research, LLC, San Antonio, Texas, United States
Fletcher Allen Health Care - Neurology Service, Burlington, Vermont, United States
Hampton Roads Neurology, Newport News, Virginia, United States
Neurological Associates, Inc, Richmond, Virginia, United States
Swedish Neuroscience Institute, Issaquah, Washington, United States
Swedish Neuroscience Institute, Seattle, Washington, United States
University of Ottawa, Ottawa, Ontario, Canada
Recherche Sepmus Inc., Greenfield Park, Quebec, Canada
Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
Contact Details
Name: Jessica Jackson
Affiliation: Opexa Therapeutics, Inc.
Role: STUDY_DIRECTOR
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