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By invitation only NCT06163508

A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells

Conditions: Transverse Myelitis

Sponsor: University of Texas Southwestern Medical Center

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Overview
This study is an observational study designed to obtain information on the long-term safety, tolerability, and continued activity of Q-Cells®. The study will follow the participants who previously received Q-Cells® for 10 years. 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.
Who can participate
Inclusion Criteria: 1. Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol. 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: 1\. The study is intended to follow all subjects who have received Q-Cells® without exception.
Interventions
Q-Cells®
DRUG
Locations 1
United States (1)
The University of Texas Southwestern Medical Center
Dallas , Texas
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
12.12.2023
Completion date
01.12.2035
Registry ID
NCT06163508
Source
clinicaltrials.gov
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