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

The University of Texas System (UT)

Status: Invitation-only

Conditions: Transverse Myelitis

Treatments: Drug: Q-Cells®

Study type: Observational

Funder types: Other

Identifiers

NCT06163508

STU-2023-0803

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

9 participants in 3 patient groups

Cohort 1: 10 microliters of Q cells

Description:

10 microliters of Q cells per site

Treatment:

Drug: Q-Cells®

Cohort 2: 15 microliters of Q cells

Description:

15 microliters of Q cells per site

Treatment:

Drug: Q-Cells®

Cohort 3: 20 microliters of Q cells

Description:

20 microliters of Q cells per site

Treatment:

Drug: Q-Cells®