Phase III Clinical Study of JadiCell™ (Umbilical Cord-Derived Mesenchymal Stem Cells) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- Proportion of Participants Alive and Free of Respiratory Failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Treatment
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
干预措施: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC. (Biological)
Control
Controls will receive two infusions of vehicle solution.
干预措施: Controls will receive two infusions of vehicle solution. (Other)
结局指标
主要结局
Proportion of Participants Alive and Free of Respiratory Failure
时间窗: 60 days
The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy.
次要结局
- 1. All-Cause Mortality(60 Days)
- 2. Survival Status(31 Days)
- 3. Incidence of Serious Adverse Events (SAEs)(31 Days)
- 4. Serious Adverse Event-Free Survival(31 Days)
- 5. Time to Clinical Recovery(Up to 60 Days)
- 6. Time to Oxygen Requirement ≤ 40%(Up to 60 Days)