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

September 24, 2025 updated by: Hope Biosciences Research Foundation

A Phase II, Open Label, Single-Center, Clinical Trial to Assess Safety and Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Sugar Land, Texas, United States, 77478
        • Hope Biosciences Stem Cell Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: HB-adMSCs
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Hospitalization for COVID-19
Time Frame: Week 0 through Week 26 (End of Study)
Number of subjects that require hospitalization for COVID-19
Week 0 through Week 26 (End of Study)
Incidence of Symptoms for COVID-19
Time Frame: 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
Week 0 through Week 26 (End of Study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absence of Upper/Lower Respiratory Infection
Time Frame: Week 0 through Week 26 (End of Study)
Absence of upper/lower respiratory infection (with hospitalization criteria)
Week 0 through Week 26 (End of Study)
Change From Baseline in Glucose
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of glucose in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Calcium
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of calcium in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Albumin
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of albumin in the blood (g/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Total Protein
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of total protein in the blood (g/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Sodium
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of sodium in the blood (mmol/L)
Weeks 0, 6, 14, 26
Change From Baseline in Total Carbon Dioxide
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of carbon dioxide in the blood (mmol/L)
Weeks 0, 6, 14, 26
Change From Baseline in Potassium
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of potassium in the blood (mmol/L)
Weeks 0, 6, 14, 26
Change From Baseline in Chloride
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of chloride in the blood (mmol/L)
Weeks 0, 6, 14, 26
Change From Baseline in Blood Urea Nitrogen (BUN)
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Creatinine
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of creatinine in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Alkaline Phosphatase
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of alkaline phosphatase in the blood (IU/L)
Weeks 0, 6, 14, 26
Change From Baseline in Alanine Aminotransferase
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of alanine aminotransferase in the blood (IU/L)
Weeks 0, 6, 14, 26
Change From Baseline in Aspartate Aminotransferase
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of aspartate aminotransferase in the blood (IU/L)
Weeks 0, 6, 14, 26
Change From Baseline in Total Bilirubin
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of total bilirubin in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Leukocytes
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of leukocytes in the blood (x 10^9/L)
Weeks 0, 6, 14, 26
Change From Baseline in Erythrocytes
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in erythrocytes in the blood (10^12/L)
Weeks 0, 6, 14, 26
Change From Baseline in Hemoglobin
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of hemoglobin in the blood (g/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Hematocrit
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in level of hematocrit in the blood (%)
Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Volume
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in mean corpuscular volume in the blood (fL)
Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Hemoglobin
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in mean corpuscular hemoglobin in the blood (pg)
Weeks 0, 6, 14, 26
Change From Baseline in Mean Corpuscular Hemoglobin Concentration
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Erythrocyte Distribution Width
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in erythrocyte distribution width in the blood (%)
Weeks 0, 6, 14, 26
Change From Baseline in Neutrophils
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in neutrophils in the blood (%) (leukocyte differential)
Weeks 0, 6, 14, 26
Change From Baseline in Lymphocytes
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in lymphocytes in the blood (%) (leukocyte differential)
Weeks 0, 6, 14, 26
Change From Baseline in Monocytes
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in monocytes in the blood (%) (leukocyte differential)
Weeks 0, 6, 14, 26
Change From Baseline in Eosinophils
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in eosinophils in the blood (%) (leukocyte differential)
Weeks 0, 6, 14, 26
Change From Baseline in Basophils
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in basophils in the blood (%) (leukocyte differential)
Weeks 0, 6, 14, 26
Change From Baseline in Platelets
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in platelets in the blood (x 10^9/L)
Weeks 0, 6, 14, 26
Change From Baseline in Prothrombin Time
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in prothrombin time in the blood (seconds)
Weeks 0, 6, 14, 26
Change From Baseline in International Normalized Ratio (INR)
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in international normalized ratio in the blood (INR) (ratio)
Weeks 0, 6, 14, 26
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)
Weeks 0, 6, 14, 26
Change From Baseline in Interleukin-6
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in Interleukin-6 in the blood (ng/L)
Weeks 0, 6, 14, 26
Change From Baseline in Interleukin-10
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in Interleukin-10 in the blood (ng/L)
Weeks 0, 6, 14, 26
Change From Baseline in C-Reactive Protein
Time Frame: Weeks 0, 6, 14, 26
Change from baseline in C-Reactive Protein in the blood (mg/dL)
Weeks 0, 6, 14, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.
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
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability.
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
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability.
Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.
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
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.
Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.
Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.
Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.
Weeks 0, 2, 6, 10, 14, 18, 22, 26
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score
Time Frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome
Weeks 0, 2, 6, 10, 14, 18, 22, 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hope Biosciences Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hope Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thanh Cheng, MD, Hope Biosciences Stem Cell Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HBCOVID01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings