Transverse MyelitisNCT06163508
A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells
An observational study of Transverse Myelitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transverse Myelitis
- What is being tested?
- Q-Cells®
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.
Who may be able to join
- 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.
Who cannot join
- 1. The study is intended to follow all subjects who have received Q-Cells® without exception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Long Term Follow-Up Study for Subjects Who Have Received Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) (LTFU Study)
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
- Being tested
- Q-Cells®
- Medical subject headings
- Myelitis, Transverse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Cells®Drug
Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 10 microliters of Q cells | 10 microliters of Q cells per site Receives: Drug: Q-Cells® | |
| Cohort 2: 15 microliters of Q cells | 15 microliters of Q cells per site Receives: Drug: Q-Cells® | |
| Cohort 3: 20 microliters of Q cells | 20 microliters of Q cells per site Receives: Drug: Q-Cells® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Safety will be assessed by the number of Adverse events.These will be recorded via physical examination findings and will be presented in data listings.
Clinically significant changes on physical exam in the areas of: general appearance, head, ears, eyes, nose, throat, neck, chest and lungs, cardiovascular, abdomen, neurological, thyroid, musculoskeletal, lymph nodes, extremities and skin, and operative site will be recorded as Adverse Events.
Measured: through study completion, an average of 10 years
Safety: Vital signs: Systolic Blood Pressure
Systolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: >180 mmHg or an increase from pre-dosing of more than 40 mmHg, or <90 mmHg or a decrease from pre-dosing of more than 30 mmHg
Measured: through study completion, an average of 10 years
Safety Endpoints: Vital signs: Diastolic Blood Pressure
Diastolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: >105 mmHg or an increase from pre-dosing of more than 30 mmHg, or <50 mmHg or a decrease from pre-dosing of more than 20 mmHg
Measured: through study completion, an average of 10 years
Safety Endpoints: Vital signs: Pulse
Pulse: Criteria for Clinically Relevant Vital Signs Abnormalities: >120 beats per minute or an increase from pre dosing of more than 20 beats per minute, or <50 beats per minute or a decrease from pre dosing of more than 20 beats per minute
Measured: through study completion, an average of 10 years
Safety Endpoints: Vital signs: Temperature
Temperature: Criteria for Clinically Relevant Vital Signs Abnormalities: >38.5°C and an increase from pre-dosing of at least 1°C
Measured: through study completion, an average of 10 years
Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 years
Number of participants with abnormal ECG readings will be summarized using descriptive statistics by original treatment cohort and visit. ECG findings that are determined to be potentially clinically significant will be summarized.
Measured: through study completion, an average of 10 years (Baseline, 10 years)
Safety Endpoints: Clinical Laboratory assessments: chemistry
Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.
Measured: through study completion, an average of 10 years
Safety Endpoints: Clinical Laboratory assessments: hematology
Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.
Measured: through study completion, an average of 10 years
Secondary outcomes (7)
Exploratory Endpoints: Visual Analog pain Scale (VAS)
Changes in pain will be assessed using VAS, a self-assessment where patients rank their current pain from 0-10.
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: American Spinal Injury Association (ASIA) Impairment Scale
Neurological changes in muscle strength and sensation via the ASIA exam.
ASIA exam yields overall scores ranked alphabetically A through E where A is the most impaired and E is normal.
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Lower Extremity Function (mobility)
NIH PROMIS scale for Lower Extremity Function is a self-assessment where patients score their lower extremity function. Higher scores in this scale are related to better outcomes.
Minimum value: 95 Maximum value: 19
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bladder Symptom Score (NBSS)
NIH PROMIS scale for NBSS is a self-assessment where patients score their bladder symptoms. Lower scores in this scale are related to better outcomes.
Minimum value: 28 Maximum value: 0
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bowel Dysfunction
NIH PROMIS scale for Neurogenic Bowel Dysfunction is a self-assessment where patients score their bowel symptoms. Lower scores in this scale are related to better outcomes.
Minimum value: 47 Maximum value: 0
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Erectile Function
NIH PROMIS scale for Erectile Function is a self-assessment where patients score their sexual function. Higher scores in this scale are related to better outcomes.
Minimum value: 5 Maximum value: 53
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Sexual Function
NIH PROMIS scale for Sexual Function is a self-assessment where patients score their sexual function. Lower scores in this scale are related to better outcomes.
Minimum value: 0 Maximum value: 263
Analysis of activities is considered exploratory and observational data from each patient will be recorded due to sample size.
Descriptive statistics (N, mean, standard deviation, median, minimum and maximum values) and change from baseline will be summarized overall and by original treatment cohort and visit.
Measured: through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start12 Dec 2023
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse MyelitisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greenberg, University of Texas Southwestern Medical Center
- Investigators
- Benjamin Greenberg, MD, Principal investigator, University of Texas Southwestern Medial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163508
- Sponsor's protocol ID
- STU-2023-0803
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow-Up Study for Subjects Who Have Received Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) (LTFU Study)
- ClinicalTrials.gov ID
- NCT06163508
- Acronym / sponsor ID
- STU-2023-0803
- Conditions
- Transverse Myelitis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 10 microliters of Q cells | – | Drug: Q-Cells®10 microliters of Q cells per site |
| Cohort 2: 15 microliters of Q cells | – | Drug: Q-Cells®15 microliters of Q cells per site |
| Cohort 3: 20 microliters of Q cells | – | Drug: Q-Cells®20 microliters of Q cells per site |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. The study is intended to follow all subjects who have received Q-Cells® without exception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-Cells®Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®. | Drug | Cohort 1: 10 microliters of Q cells, Cohort 2: 15 microliters of Q cells, Cohort 3: 20 microliters of Q cells |
Primary outcome
Number of Adverse Events
Time frame: through study completion, an average of 10 years
Safety will be assessed by the number of Adverse events.These will be recorded via physical examination findings and will be presented in data listings. Clinically significant changes on physical exam in the areas of: general appearance, head, ears, eyes, nose, throat, neck, chest and lungs, cardiovascular, abdomen, neurological, thyroid, musculoskeletal, lymph nodes, extremities and skin, and operative site will be recorded as Adverse Events.
Safety: Vital signs: Systolic Blood Pressure
Time frame: through study completion, an average of 10 years
Systolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: >180 mmHg or an increase from pre-dosing of more than 40 mmHg, or <90 mmHg or a decrease from pre-dosing of more than 30 mmHg
Safety Endpoints: Vital signs: Diastolic Blood Pressure
Time frame: through study completion, an average of 10 years
Diastolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: >105 mmHg or an increase from pre-dosing of more than 30 mmHg, or <50 mmHg or a decrease from pre-dosing of more than 20 mmHg
Safety Endpoints: Vital signs: Pulse
Time frame: through study completion, an average of 10 years
Pulse: Criteria for Clinically Relevant Vital Signs Abnormalities: >120 beats per minute or an increase from pre dosing of more than 20 beats per minute, or <50 beats per minute or a decrease from pre dosing of more than 20 beats per minute
Safety Endpoints: Vital signs: Temperature
Time frame: through study completion, an average of 10 years
Temperature: Criteria for Clinically Relevant Vital Signs Abnormalities: >38.5°C and an increase from pre-dosing of at least 1°C
Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 years
Time frame: through study completion, an average of 10 years (Baseline, 10 years)
Number of participants with abnormal ECG readings will be summarized using descriptive statistics by original treatment cohort and visit. ECG findings that are determined to be potentially clinically significant will be summarized.
Safety Endpoints: Clinical Laboratory assessments: chemistry
Time frame: through study completion, an average of 10 years
Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.
Safety Endpoints: Clinical Laboratory assessments: hematology
Time frame: through study completion, an average of 10 years
Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.
7 secondary outcomes
Exploratory Endpoints: Visual Analog pain Scale (VAS)
Time frame: through study completion, an average of 10 years
Neurological change: American Spinal Injury Association (ASIA) Impairment Scale
Time frame: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Lower Extremity Function (mobility)
Time frame: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bladder Symptom Score (NBSS)
Time frame: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Neurogenic Bowel Dysfunction
Time frame: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Erectile Function
Time frame: through study completion, an average of 10 years
Neurological change: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life Questionnaire: Sexual Function
Time frame: through study completion, an average of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Greenberg, MD principal investigator
University of Texas Southwestern Medial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transverse Myelitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: through study completion, an average of 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.