By InvitationNot Applicable

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

United States9 participantsStarted 2023-12-12

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Adverse Events

Timeframe: through study completion, an average of 10 years

Safety: Vital signs: Systolic Blood Pressure

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Diastolic Blood Pressure

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Pulse

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Temperature

Timeframe: through study completion, an average of 10 years

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)

Safety Endpoints: Clinical Laboratory assessments: chemistry

Timeframe: through study completion, an average of 10 years

Trial details

NCT IDNCT06163508

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-12

View on ClinicalTrials.gov More Transverse Myelitis trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Adverse Events

Timeframe: through study completion, an average of 10 years

Safety: Vital signs: Systolic Blood Pressure

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Diastolic Blood Pressure

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Pulse

Timeframe: through study completion, an average of 10 years

Safety Endpoints: Vital signs: Temperature

Timeframe: through study completion, an average of 10 years

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)

Safety Endpoints: Clinical Laboratory assessments: chemistry

Timeframe: through study completion, an average of 10 years