A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells
Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Dec 6, 2023
Trial Information
Current as of November 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a long-term, observational follow-up study at the University of Texas Southwestern Medical Center to learn about the safety and any lasting effects of Q-Cells® (a type of stem cell therapy) in people with transverse myelitis. Researchers will track participants who previously received Q-Cells to see how they are doing over about 10 years. There are three groups based on the amount of Q-Cells given (10, 15, or 20 microliters per site). Because this is an observational study, no new treatment is given; instead, doctors will monitor safety (side effects, vital signs, ECGs, and routine labs) and look at changes in pain, nerve function and mobility, bladder and bowel symptoms, sexual function, and overall quality of life, using exams, imaging, and questionnaires.
Who can join? Children and adults who already received Q-Cells as part of Protocol QTM-101 or another protocol, and who can understand the study and give informed consent. About nine people are expected to enroll, and participation is by invitation. If you join, you’ll have safety checks, lab tests, imaging, and surveys over up to 10 years. The study is overseen as a U.S. FDA-regulated drug study, led by Dr. Benjamin Greenberg at UT Southwestern. Results are not available yet, and the study is still enrolling by invitation, with an estimated completion around 2035.
Gender
ALL
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.
About University Of Texas Southwestern Medical Center
The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dallas, Texas, United States
Patients applied
Trial Officials
Benjamin Greenberg, MD
Principal Investigator
University of Texas Southwestern Medial Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported