Набор по приглашению NCT06163508

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

— Наблюдательное Transverse Myelitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Q-Cells®.
Кому может быть актуально: Состояния в реестре: Transverse Myelitis. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

Number of Adverse Events [Срок оценки: through study completion, an average of 10 years]
Safety: Vital signs: Systolic Blood Pressure [Срок оценки: through study completion, an average of 10 years]
Safety Endpoints: Vital signs: Diastolic Blood Pressure [Срок оценки: through study completion, an average of 10 years]
Safety Endpoints: Vital signs: Pulse [Срок оценки: through study completion, an average of 10 years]
Safety Endpoints: Vital signs: Temperature [Срок оценки: through study completion, an average of 10 years]
Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 years [Срок оценки: through study completion, an average of 10 years (Baseline, 10 years)]
Safety Endpoints: Clinical Laboratory assessments: chemistry [Срок оценки: through study completion, an average of 10 years]
Safety Endpoints: Clinical Laboratory assessments: hematology [Срок оценки: through study completion, an average of 10 years]

Вторичные конечные точки (7)

Exploratory Endpoints: Visual Analog pain Scale (VAS) [Срок оценки: through study completion, an average of 10 years]
Neurological change: American Spinal Injury Association (ASIA) Impairment Scale [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through study completion, an average of 10 years]

Критерии участия

Критерии включения

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.