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Набор скоро начнётся NCT07479043

To Evaluate the Safety and Potential Therapeutic Activity of JadiCell™, an Investigational Umbilical Cord-Derived Mesenchymal Stem Cell Therapy, in Patients Diagnosed With Acute Respiratory Distress Syndrome (ARDS).

Фаза III С лечением Acute Respiratory Distress Syndrome

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: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC., Controls will receive two infusions of vehicle solution..
Кому может быть актуально
Состояния в реестре: Acute Respiratory Distress Syndrome. Базовые параметры: 18 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Phase III Clinical Study of JadiCell™ (Umbilical Cord-Derived Mesenchymal Stem Cells) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Обзор

This study evaluates the safety and potential therapeutic activity of JadiCell™, an investigational umbilical cord-derived mesenchymal stem cell therapy, in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). JadiCells are administered intravenously and are intended to modulate inflammatory responses and promote tissue repair in injured lung tissue.

Подробное описание

Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by severe inflammatory lung injury, impaired oxygen exchange, and high mortality. Current treatments are primarily supportive and include mechanical ventilation and intensive care management.

JadiCell™ is an investigational cellular therapy derived from human umbilical cord tissue. These cells possess immunomodulatory and regenerative properties and may reduce inflammatory lung injury through paracrine signaling, immune regulation, and tissue repair mechanisms.

Following intravenous administration, mesenchymal stem cells are known to localize within the pulmonary microvasculature where they interact with immune cells and injured lung tissue.

This study will evaluate the safety and potential clinical effects of intravenous JadiCell administration in patients with ARDS.

Вмешательства

  • Биопрепарат Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
    Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
  • Другое Controls will receive two infusions of vehicle solution.
    Subjects in the control group will be treated with two IV infusions of vehicle solution.

Первичные конечные точки

  • Proportion of Participants Alive and Free of Respiratory Failure [Срок оценки: 60 days]
Вторичные конечные точки (6)
  • 1. All-Cause Mortality [Срок оценки: 60 Days]
  • 2. Survival Status [Срок оценки: 31 Days]
  • 3. Incidence of Serious Adverse Events (SAEs) [Срок оценки: 31 Days]
  • 4. Serious Adverse Event-Free Survival [Срок оценки: 31 Days]
  • 5. Time to Clinical Recovery [Срок оценки: Up to 60 Days]
  • 6. Time to Oxygen Requirement ≤ 40% [Срок оценки: Up to 60 Days]

Критерии участия

Критерии включения

  • Patients currently hospitalized
  • Laboratory confirmation of ARDS
  • Aged between 18 and 80 years
  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
  • SpO2 <94% on room air requiring supplemental oxygen above baseline
  • PaO2/FiO2 <300 mmHg
  • Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
  • Requiring one of the following ï High Flow Oxygen Therapy ï Non-invasive Positive Pressure Ventilation (NIPPV, e.g. BiPAP and CPAP) ï Invasive Mechanical Ventilation (INV = intubated)

Критерии исключения

  • Greater than 96 h since hospitalization at the time of enrollment
  • Greater than 48 h since intubation at the time of enrollment
  • A previous MSC infusion not related to this trial
  • History of Pulmonary Hypertension (WHO Class III/IV)
  • History of left atrial hypertension or decompensated left heart failure.
  • Pregnant or lactating patient
  • Unstable arrhythmia
  • Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily
  • Patients currently receiving chronic dialysis
  • Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
  • Presence of any active malignancy (except non-melanoma skin cancer)
  • Moderate to severe liver disease (AST and ALT >5 X ULN)
  • Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen at rest
  • Septic Shock (with >1 vasopressor)
  • Multi-organ failure
  • Not expected to survive > 48 hours

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07479043 · BRTH001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗