NCT04445220Unknown1 期
A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Safety and tolerability as measured by incidence of IP-related serious adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood cultures for systemic infection, active urinary sediment to suggest UTI, or any imaging supportive of a clinical diagnosis of infection, for example, pulmonary infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal collection, etc.
- •AKI as determined by the Investigator based on his/her clinical judgment
- •Receiving or planned to receive RRT in < 24 hours
- •Able to tolerate indwelling intravascular access
- •Has tolerated CRRT for at least 6 hours prior to IP treatment
- •Have maintained hemodynamic stability for at least 6 hours prior to IP treatment with only minor changes in pressure support medication required (if used)
- •Vascular access (catheter placement) is patent and capable of supporting CRRT for the duration of IP treatment
- •Likely to require RRT for at least an additional 48 hours
- •Potassium level >3.6 and <5.5 mEq/L or >3.6 and < 5.5 mmol/L prior to IP treatment
- •SaO2 > 92% prior to IP initiation
- •Blood pH > 7.2 prior to IP initiation
- •Medically cleared to receive anticoagulation per institutional standard of care / PI prescribed protocol and meeting protocol defined anticoagulation targets prior to receipt of IP
- •Ability to give informed consent or have a legally authorized representative do so
排除标准
- •Female subjects who are pregnant, planning to become pregnant, or lactating
- •MAP <70 mmHg immediately prior to IP initiation
- •Systolic blood pressure < 90 mmHg immediately prior to IP initiation
- •Mechanical ventilator support requiring FiO2 > 80% prior to IP initiation
- •Receiving extracorporeal membrane oxygenation (ECMO)
- •Liver disease with Child Pugh score of > 7 prior to IP initiation
- •High sensitivity cardiac Troponin level (hs-cTn) > 100.0 ng/L prior to IP initiation or other equivalent Troponin test result prior to IP initiation
- •Hepatorenal syndrome
- •AKI due to post-renal outflow obstruction
- •Acute or chronic vasculitis of any etiology
- •Chronic systemic infection
- •Subjects with a past medical history of an inherited or acquired hypercoagulable condition independent of COVID-19
- •Patients with a past medical history of an allergic response to MSC therapy
- •Participation in another interventional trial with the exception of studies of antivirals, corticosteroids, hydroxychloroquine, azithromycin, or angiotensin converting enzyme inhibitors/angiotensin receptor blockers (or related compounds)
- •Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer
- •Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability, or subjects who have reached the institutionally defined maximum level of vasopressor support within 12 hours of intended IP integration
- •Imminent death in <24 hours
- •Organ failure affecting more than 2 non-renal organs
- •Platelet count <50,000/μL or other serious hematological abnormalities that would place subject in imminent danger of death
- •Lactate levels >8 mmol/L suggestive of severe end-organ hypoperfusion prior to the time of IP integration
- •Any prior medical condition or recent surgical procedure, planned significant medical interventions or procedures that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
研究组 & 干预措施
Case controls
No Intervention
Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.
High dose cohort
Experimental
SBI-101 device containing 750 million MSCs
干预措施: SBI-101 (Biological)
Low dose cohort
Experimental
SBI-101 device containing 250 million MSCs
干预措施: SBI-101 (Biological)
结局指标
主要结局
Safety and tolerability as measured by incidence of IP-related serious adverse events
时间窗: Outcomes and Serious Adverse Events through Day 180
次要结局
未报告次要终点
研究者
研究点 (2)
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