NCT04490486撤回1 期
Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms
Joshua M Hare0 个研究点开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Percent of participants with treatment related Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms
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
- Double (Participant, Investigator)
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
- •Provide written informed consent
- •Male or female subjects age > 18 years at the time of signing the Informed Consent Form.
- •COVID-19 positive according to diagnosis (evaluated by reverse transcription (RT)-polymerase chain reaction (PCR) test confirming infection with severe acute respiratory syndrome coronavirus and clinical management of COVID-19 criteria (refer to appendix B)
- •Individuals with moderate to severe COVID-19 symptoms.
- •Moderate:
- •Patients with moderate disease are symptomatic (e.g. fever, cough, headache, myalgia, sore throat, nasal congestion, nausea, vomiting, diarrhea, fatigue, anosmia, or dysgeusia) and have abnormal chest imaging or some degree of hypoxia requiring supplemental oxygen but not intubation.
- •Moderate-severe:
- •The Moderately Severe disease category includes patients who are symptomatic (as described above), have abnormal chest imaging, but also have worsening hypoxia compatible with mild acute respiratory distress syndrome (ARDS) (Partial Pressure of Oxygen (PaO2)/Fraction of Inspired Oxygen (FiO2) </= 300 but > 200) - Berlin criteria; but do not yet require intubation .
- •Adequate venous access
- •For female patients only, willingness to use FDA-recommended birth control until 6 months post treatment.
- •Must agree to comply with all study requirements and be willing to complete all study visits.
- •Need in-patient admission
排除标准
- •PaO2/FiO2 </= 200
- •Anticipated intubation within 24h
- •Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening and prior to infusion.
- •Inability to perform any of the assessments required for endpoint analysis.
- •Subjects that are unsuitable with the study requirements .
- •Active listing (or expected future listing) for transplant of any organ.
- •Have known allergies to penicillin or streptomycin.
- •Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
- •Have a history of organ or cell transplant rejection
- •Has a history of an adverse response to cell-based therapy
- •Have presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 1 year.
- •History of active drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
- •Be serum positive for HIV, Surface antigen of Hepatitis B virus (HBsAg) or Viremic hepatitis C.
- •Severe hepatic impairment (defined as liver cirrhosis Child stage B or C);
- •Stage 4 chronic kidney disease or currently receiving chronic dialysis;
- •Advanced cardiac (eg, severe heart failure [New York Heart Association (NYHA) III-IV]) or pulmonary diseases;
- •Has uncontrolled hypertension as defined by BP systolic above 180 and diastolic above 110 which, in the Investigator's judgment, would not make participation appropriate;
- •Known allergy or hypersensitivity to stem cell infusions or its components;
- •Current enrollment in an investigational drug or participation in such a study within 15 days of entry into this study;
- •Moderate to severe liver failure (Childs-Pugh Score > 10) Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) > 5 times the upper limit of normal;
- •Congenital prolonged QT syndrome;
- •Current QT corrected (QTc) above 490 msec. If patient has Q, R and S waves (QRS) interval greater or equal to 120 msec, then the QT/QTc will be normalized to a QRS interval of 110 msec. (For instance, if the patient has a bundle branch block with QRS of 140 msec and QT/QTc of 470 msec, the normalized QTc will be 470;
- •Subjects taking drugs that could affect the QT interval (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin);
- •Anticipated transfer to another hospital which is not a study site within 72 hours;
- •Coagulopathy (Platelets less than 80,000, or Prothrombin Time (PT)/Partial Thromboplastin time (PTT) twice normal range without systemic anticoagulation;
- •Greater than 24h since first meeting ARDS criteria (Berlin definition) or 72h of ICU admission;
- •Subjects who are legally detained in an official institution;
- •A previous MSC infusion in last 30 days not related to this trial;
- •History of Pulmonary Hypertension (WHO Class III/IV);
- •Unstable arrhythmia or uncontrolled hypertension not responding to best ICU treatment;
- •Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO);
- •Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
- •Moribund patient not expected to survive > 24 hours;
- •The investigator believes that participating in the trial is not in the best interest of the patient, or the investigator considers patient unsuitable for enrollment (such as unpredictable risks or subject compliance issues)
结局指标
主要结局
Percent of participants with treatment related Serious Adverse Events (SAE)
时间窗: 12 months
Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.
次要结局
- Rate of Mortality(Up to 30 Days)
- Change in systemic inflammatory marker levels(Baseline, Day 30)
- COVID-19 Viral Load(Up to 30 Days)
- Change in SOFA score(Baseline, Up to 30 Days)
- Change in LDH levels(Baseline, Up to 30 Days)
- Change in inflammatory marker levels(Baseline, Day 30)
- Change in electrolytes levels(Baseline, Up to 30 Days)
- Percentage of participants with changes in immune marker expression(Up to 30 Days)
- Number of subjects discharged from the ICU(Up to 7 Days)
- Percentage of participants with less requirement for vasoactive agents(Up to 30 Days)
- Percentage of participants with changes in radiologic findings(Up to 30 Days)
- Percentage of participants with less pneumonia symptoms(Up to 30 Days)
研究者
Joshua M Hare
Director of ISCI, Louis Lemberg Professor of Medicine
University of Miami
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