Clinical trial NCT06163508: A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells
Official title: A Long Term Follow-Up Study for Subjects Who Have Received Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) (LTFU Study)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Transverse Myelitis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: through study completion, an average of 10 years
measure: Safety: Vital signs: Systolic Blood Pressure
timeFrame: through study completion, an average of 10 years
measure: Safety Endpoints: Vital signs: Diastolic Blood Pressure
timeFrame: through study completion, an average of 10 years
measure: Safety Endpoints: Vital signs: Pulse
timeFrame: through study completion, an average of 10 years
measure: Safety Endpoints: Vital signs: Temperature
timeFrame: through study completion, an average of 10 years
measure: Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 years
timeFrame: through study completion, an average of 10 years (Baseline, 10 years)
measure: Safety Endpoints: Clinical Laboratory assessments: chemistry
timeFrame: through study completion, an average of 10 years
measure: Safety Endpoints: Clinical Laboratory assessments: hematology
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
measure: Exploratory Endpoints: Visual Analog pain Scale (VAS)
timeFrame: through study completion, an average of 10 years
measure: Neurological change: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: through study completion, an average of 10 years
measure: Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Lower Extremity Function (mobility)
timeFrame: through study completion, an average of 10 years
measure: Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: through study completion, an average of 10 years
measure: Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bowel Dysfunction
timeFrame: through study completion, an average of 10 years
measure: Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Erectile Function
timeFrame: through study completion, an average of 10 years
measure: Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Sexual Function
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medial Center
name: Benjamin Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: