A Phase II, Open Label, Single-Center, Clinical Trial to Assess Safety and Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Incidence of Symptoms for COVID-19
研究概览
简要总结
Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
详细描述
This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 51 patients were enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either 65 years of age or older, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary objective of this study is to provide immune support against COVID-19, measured by the presence or absence of adverse events and serious adverse events related to the study drug. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.
- •Men, and women 65 years of age or older (according to CDC provisions) OR
- •Participant works in healthcare facility or other well characterized high-risk environment OR
- •Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease.
- •Subject must have previously banked their cells at Hope Biosciences
- •No signs or symptoms of infection, including but not limited to, body temperature >100 F and pulse rate > 100 BPM.
- •Subject provides written informed consent prior to initiation of any study procedures.
- •Agrees to the collection of venous blood per protocol.
- •Agrees to conformational testing for SARS-CoV-2 before end of study.
排除标准
- •Subjects must not have any of the following criteria to be eligible.
- •Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures
- •Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days;
- •Inability to provide informed consent or to comply with test requirements;
- •Any medical disease or condition that, in the opinion of the site PI or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- •Patients who have received a stem cell treatment within one year.
- •Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
- •Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days
研究组 & 干预措施
HB-adMSCs
Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26.
干预措施: HB-adMSCs (Biological)
结局指标
主要结局
Incidence of Symptoms for COVID-19
时间窗: Week 0 through Week 26 (End of Study)
Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough
Incidence of Hospitalization for COVID-19
时间窗: Week 0 through Week 26 (End of Study)
Number of subjects that require hospitalization for COVID-19
次要结局
- Change From Baseline in Platelets(Weeks 0, 6, 14, 26)
- Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)(Weeks 0, 6, 14, 26)
- Change From Baseline in Calcium(Weeks 0, 6, 14, 26)
- Change From Baseline in Alanine Aminotransferase(Weeks 0, 6, 14, 26)
- Change From Baseline in Albumin(Weeks 0, 6, 14, 26)
- Change From Baseline in Chloride(Weeks 0, 6, 14, 26)
- Change From Baseline in Total Protein(Weeks 0, 6, 14, 26)
- Change From Baseline in Sodium(Weeks 0, 6, 14, 26)
- Change From Baseline in Total Carbon Dioxide(Weeks 0, 6, 14, 26)
- Change From Baseline in Potassium(Weeks 0, 6, 14, 26)
- Change From Baseline in Mean Corpuscular Hemoglobin Concentration(Weeks 0, 6, 14, 26)
- Change From Baseline in Erythrocyte Distribution Width(Weeks 0, 6, 14, 26)
- Absence of Upper/Lower Respiratory Infection(Week 0 through Week 26 (End of Study))
- Change From Baseline in Glucose(Weeks 0, 6, 14, 26)
- Change From Baseline in Blood Urea Nitrogen (BUN)(Weeks 0, 6, 14, 26)
- Change From Baseline in Creatinine(Weeks 0, 6, 14, 26)
- Change From Baseline in Aspartate Aminotransferase(Weeks 0, 6, 14, 26)
- Change From Baseline in Erythrocytes(Weeks 0, 6, 14, 26)
- Change From Baseline in Alkaline Phosphatase(Weeks 0, 6, 14, 26)
- Change From Baseline in Leukocytes(Weeks 0, 6, 14, 26)
- Change From Baseline in Hemoglobin(Weeks 0, 6, 14, 26)
- Change From Baseline in Lymphocytes(Weeks 0, 6, 14, 26)
- Change From Baseline in Basophils(Weeks 0, 6, 14, 26)
- Change From Baseline in Total Bilirubin(Weeks 0, 6, 14, 26)
- Change From Baseline in Hematocrit(Weeks 0, 6, 14, 26)
- Change From Baseline in Mean Corpuscular Hemoglobin(Weeks 0, 6, 14, 26)
- Change From Baseline in Monocytes(Weeks 0, 6, 14, 26)
- Change From Baseline in Eosinophils(Weeks 0, 6, 14, 26)
- Change From Baseline in International Normalized Ratio (INR)(Weeks 0, 6, 14, 26)
- Change From Baseline in Neutrophils(Weeks 0, 6, 14, 26)
- Change From Baseline in Prothrombin Time(Weeks 0, 6, 14, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Mean Corpuscular Volume(Weeks 0, 6, 14, 26)
- Change From Baseline in Interleukin-6(Weeks 0, 6, 14, 26)
- Change From Baseline in Interleukin-10(Weeks 0, 6, 14, 26)
- Change From Baseline in C-Reactive Protein(Weeks 0, 6, 14, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health(Weeks 0, 2, 6, 10, 14, 18, 22, 26)
- Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health(Weeks 0, 2, 6, 10, 14, 18, 22, 26)