A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells
NCT ID: NCT06163508
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
9 participants
OBSERVATIONAL
2023-12-12
2035-12-31
Brief Summary
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The goal of this observational study is to learn about the long term effects of Q-Cells® in people with transverse myelitis.
The main objectives the study is to evaluate the safety of patients who have received Q-Cells®.
The secondary goal of the study is to get data about the long-term activity of Q-Cells® over a period of 10 years.
Patients will complete exams, lab tests, imaging, and questionnaires to monitor their safety.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: 10 microliters of Q cells
10 microliters of Q cells per site
Q-Cells®
Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.
Cohort 2: 15 microliters of Q cells
15 microliters of Q cells per site
Q-Cells®
Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.
Cohort 3: 20 microliters of Q cells
20 microliters of Q cells per site
Q-Cells®
Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.
Interventions
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Q-Cells®
Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.
Exclusion Criteria
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Benjamin Greenberg
Benjamin M. Greenberg, Principal Investigator
Principal Investigators
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Benjamin Greenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medial Center
Locations
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The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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STU-2023-0803
Identifier Type: -
Identifier Source: org_study_id
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