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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06163508
Status
Enrolling By Invitation

Conditions

  • Transverse Myelitis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Q-Cells® — DRUG
    Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Study Details

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.

Key Dates

Start date
Dec 12, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
9 participants (estimated)

Arms

  • Arm: Cohort 1: 10 microliters of Q cells
    10 microliters of Q cells per site
  • Arm: Cohort 2: 15 microliters of Q cells
    15 microliters of Q cells per site
  • Arm: Cohort 3: 20 microliters of Q cells
    20 microliters of Q cells per site

Primary Outcome Measure

Number of Adverse Events [ Time Frame: through study completion, an average of 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Southwestern Medical CenterDallasTexas75390-

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The University of Texas Southwestern Medical Center· Dallas, TX

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