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Идёт набор NCT06794294

Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease

Фаза I / Фаза II С лечением Rotator Cuff Disease

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: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Disease. Базовые параметры: от 19 лет · 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
South Korea
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 Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease

Обзор

The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease

Вмешательства

  • Биопрепарат Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
    Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 1x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the

Первичные конечные точки

  • Shoulder pain and disability index(SPADI) Score [Срок оценки: 6 months]
Вторичные конечные точки (5)
  • Constant-Murley score [Срок оценки: 6 months]
  • Visual Analog Scale(VAS) pain in motion [Срок оценки: 6 months]
  • Changes in the size of rotator cuff tears determined by MRI [Срок оценки: 6 months]
  • Changes in the size of rotator cuff tears determined by arthroscopy [Срок оценки: 6 months]
  • Adverse event [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Male or female 19 years of age and older.
  • Patients with unilateral shoulder pain lasting for at least 3months
  • Patients who do not respond to conservative treatment.
  • Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months
  • Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
  • Patients without any restrictions on clinical trial procedures, including hospitalization.

Критерии исключения

  • Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.
  • Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months
  • Patients with a history of receiving stem cell therapy for the shoulder.
  • Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.
  • Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.
  • Patients presenting with symptomatic cervical spine disorders.
  • Patients with concurrent bilateral shoulder pain
  • Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
  • Patients with neurological deficit
  • Pregnant women or lactating mothers.
  • Patients unwilling to use effective contraception during the clinical trial period.
  • Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test.
  • Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies.
  • Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication.
  • Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules.
  • Patients who have participated in another clinical trial within the last 3 months.
  • Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Se — Seoul

Идентификаторы

NCT: NCT06794294 · ASB-IP-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗