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Enrolling by Invitation

NCT Number: NCT06163508

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

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.

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Key information

Conditions

Transverse Myelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Central Nervous System Diseases Central Nervous System Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Myelitis Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuroinflammatory Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Spinal Cord Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • The study is intended to follow all subjects who have received Q-Cells® without exception.

Treatment and study plan

Q-Cells®

Drug

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Exploratory Endpoints: Visual Analog pain Scale (VAS)

    Time frame: through study completion, an average of 10 years

    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.

  2. Neurological change: American Spinal Injury Association (ASIA) Impairment Scale

    Time frame: through study completion, an average of 10 years

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2035
Study completion
2035
First posted
Dec 11, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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