NCT06163508

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 9 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Transverse Myelitis

Interventions

Type	Name	Description
DRUG	Q-Cells®	Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Timeline

• Start date: 2023-12-12
• Primary completion: 2035-12-01
• Completion: 2035-12-01
• First posted: 2023-12-11
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study