A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: HB-adMSCs
Intervention description: Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coronavirus; Prevention; Immune support; stem cells; mesenchymal stem cells; adipose-derived mesenchymal stem cells

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.

          1. Men, and women 65 years of age or older (according to CDC provisions) OR

          2. Participant works in healthcare facility or other well characterized high-risk
             environment OR

          3. Has underlying conditions including but not limited to cardiopathies, diabetes
             mellitus, cancer, COPD, asthma or any other systemic autoimmune disease.

          4. Subject must have previously banked their cells at Hope Biosciences

          5. No signs or symptoms of infection, including but not limited to, body temperature >100
             F and pulse rate > 100 BPM.

          6. Subject provides written informed consent prior to initiation of any study procedures.

          7. Agrees to the collection of venous blood per protocol.

          8. Agrees to conformational testing for SARS-CoV-2 before end of study.

        Exclusion Criteria:

        Subjects must not have any of the following criteria to be eligible.

          1. Women who are pregnant or lactating, or those who are not pregnant but do not take
             effective contraceptive measures

          2. Patients who are participating in other clinical trials or have intake of
             investigational drug within the previous 30 days;

          3. Inability to provide informed consent or to comply with test requirements;

          4. 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.

          5. Patients who have received a stem cell treatment within one year.

          6. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time
             prior to or during the study.

          7. Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19
             associated symptoms within the past 30-days