A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19

Hope Biosciences Research Foundation51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

HB-adMSCsBIOLOGICAL

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, United States

Outcomes

Primary Outcomes

Incidence of Hospitalization for COVID-19

Number of subjects that require hospitalization for COVID-19

Time frame: Week 0 through Week 26 (End of Study)

Incidence of Symptoms for COVID-19

Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough

Time frame: Week 0 through Week 26 (End of Study)

Secondary Outcomes

Absence of Upper/Lower Respiratory Infection

Absence of upper/lower respiratory infection (with hospitalization criteria)

Time frame: Week 0 through Week 26 (End of Study)

Change From Baseline in Glucose

Change from baseline in level of glucose in the blood (mg/dL)