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Enrolling by invitation NCT06163508

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

— Observational Transverse Myelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Q-Cells®.
Who it may be relevant to
Registry conditions: Transverse Myelitis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Long Term Follow-Up Study for Subjects Who Have Received Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) (LTFU Study)

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.

Interventions

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

Primary outcome measures

  • Number of Adverse Events [Time frame: through study completion, an average of 10 years]
  • Safety: Vital signs: Systolic Blood Pressure [Time frame: through study completion, an average of 10 years]
  • Safety Endpoints: Vital signs: Diastolic Blood Pressure [Time frame: through study completion, an average of 10 years]
  • Safety Endpoints: Vital signs: Pulse [Time frame: through study completion, an average of 10 years]
  • Safety Endpoints: Vital signs: Temperature [Time frame: through study completion, an average of 10 years]
  • Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 years [Time frame: through study completion, an average of 10 years (Baseline, 10 years)]
  • Safety Endpoints: Clinical Laboratory assessments: chemistry [Time frame: through study completion, an average of 10 years]
  • Safety Endpoints: Clinical Laboratory assessments: hematology [Time frame: through study completion, an average of 10 years]
Secondary outcome measures (7)
  • Exploratory Endpoints: Visual Analog pain Scale (VAS) [Time frame: through study completion, an average of 10 years]
  • Neurological change: American Spinal Injury Association (ASIA) Impairment Scale [Time frame: through study completion, an average of 10 years]
  • Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Lower Extremity Function (mobility) [Time frame: through study completion, an average of 10 years]
  • Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bladder Symptom Score (NBSS) [Time frame: through study completion, an average of 10 years]
  • Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bowel Dysfunction [Time frame: through study completion, an average of 10 years]
  • Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Erectile Function [Time frame: through study completion, an average of 10 years]
  • Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Sexual Function [Time frame: through study completion, an average of 10 years]

Eligibility criteria

Inclusion criteria

  • Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT06163508 · STU-2023-0803

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗