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COVID-19Phase 2NCT04349631

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

A Phase 2 study testing HB-adMSCs in people with COVID-19, run by Hope Biosciences Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
HB-adMSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
20 Apr 2020to 25 Nov 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hope Biosciences Stem Cell Research Foundation

    Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
COVID-19
Being tested
HB-adMSCs
Keywords
Coronavirus, Prevention, Immune support, stem cells, mesenchymal stem cells, adipose-derived mesenchymal stem cells
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04349631
Study groupRoleWhat they receive
HB-adMSCsExperimentalFive 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.
Receives: Biological: HB-adMSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Hospitalization for COVID-19

    Number of subjects that require hospitalization for COVID-19

    Measured: Week 0 through Week 26 (End of Study)

  2. 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

    Measured: Week 0 through Week 26 (End of Study)

Secondary outcomes (44)

  1. Absence of Upper/Lower Respiratory Infection

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

    Measured: Week 0 through Week 26 (End of Study)

  2. Change From Baseline in Glucose

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

    Measured: Weeks 0, 6, 14, 26

  3. Change From Baseline in Calcium

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

    Measured: Weeks 0, 6, 14, 26

  4. Change From Baseline in Albumin

    Change from baseline in level of albumin in the blood (g/dL)

    Measured: Weeks 0, 6, 14, 26

  5. Change From Baseline in Total Protein

    Change from baseline in level of total protein in the blood (g/dL)

    Measured: Weeks 0, 6, 14, 26

  6. Change From Baseline in Sodium

    Change from baseline in level of sodium in the blood (mmol/L)

    Measured: Weeks 0, 6, 14, 26

  7. Change From Baseline in Total Carbon Dioxide

    Change from baseline in level of carbon dioxide in the blood (mmol/L)

    Measured: Weeks 0, 6, 14, 26

  8. Change From Baseline in Potassium

    Change from baseline in level of potassium in the blood (mmol/L)

    Measured: Weeks 0, 6, 14, 26

  9. Change From Baseline in Chloride

    Change from baseline in level of chloride in the blood (mmol/L)

    Measured: Weeks 0, 6, 14, 26

  10. Change From Baseline in Blood Urea Nitrogen (BUN)

    Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)

    Measured: Weeks 0, 6, 14, 26

  11. Change From Baseline in Creatinine

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

    Measured: Weeks 0, 6, 14, 26

  12. Change From Baseline in Alkaline Phosphatase

    Change from baseline in level of alkaline phosphatase in the blood (IU/L)

    Measured: Weeks 0, 6, 14, 26

  13. Change From Baseline in Alanine Aminotransferase

    Change from baseline in level of alanine aminotransferase in the blood (IU/L)

    Measured: Weeks 0, 6, 14, 26

  14. Change From Baseline in Aspartate Aminotransferase

    Change from baseline in level of aspartate aminotransferase in the blood (IU/L)

    Measured: Weeks 0, 6, 14, 26

  15. Change From Baseline in Total Bilirubin

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

    Measured: Weeks 0, 6, 14, 26

  16. Change From Baseline in Leukocytes

    Change from baseline in level of leukocytes in the blood (x 10^9/L)

    Measured: Weeks 0, 6, 14, 26

  17. Change From Baseline in Erythrocytes

    Change from baseline in erythrocytes in the blood (10^12/L)

    Measured: Weeks 0, 6, 14, 26

  18. Change From Baseline in Hemoglobin

    Change from baseline in level of hemoglobin in the blood (g/dL)

    Measured: Weeks 0, 6, 14, 26

  19. Change From Baseline in Hematocrit

    Change from baseline in level of hematocrit in the blood (%)

    Measured: Weeks 0, 6, 14, 26

  20. Change From Baseline in Mean Corpuscular Volume

    Change from baseline in mean corpuscular volume in the blood (fL)

    Measured: Weeks 0, 6, 14, 26

  21. Change From Baseline in Mean Corpuscular Hemoglobin

    Change from baseline in mean corpuscular hemoglobin in the blood (pg)

    Measured: Weeks 0, 6, 14, 26

  22. Change From Baseline in Mean Corpuscular Hemoglobin Concentration

    Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)

    Measured: Weeks 0, 6, 14, 26

  23. Change From Baseline in Erythrocyte Distribution Width

    Change from baseline in erythrocyte distribution width in the blood (%)

    Measured: Weeks 0, 6, 14, 26

  24. Change From Baseline in Neutrophils

    Change from baseline in neutrophils in the blood (%) (leukocyte differential)

    Measured: Weeks 0, 6, 14, 26

  25. Change From Baseline in Lymphocytes

    Change from baseline in lymphocytes in the blood (%) (leukocyte differential)

    Measured: Weeks 0, 6, 14, 26

  26. Change From Baseline in Monocytes

    Change from baseline in monocytes in the blood (%) (leukocyte differential)

    Measured: Weeks 0, 6, 14, 26

  27. Change From Baseline in Eosinophils

    Change from baseline in eosinophils in the blood (%) (leukocyte differential)

    Measured: Weeks 0, 6, 14, 26

  28. Change From Baseline in Basophils

    Change from baseline in basophils in the blood (%) (leukocyte differential)

    Measured: Weeks 0, 6, 14, 26

  29. Change From Baseline in Platelets

    Change from baseline in platelets in the blood (x 10^9/L)

    Measured: Weeks 0, 6, 14, 26

  30. Change From Baseline in Prothrombin Time

    Change from baseline in prothrombin time in the blood (seconds)

    Measured: Weeks 0, 6, 14, 26

  31. Change From Baseline in International Normalized Ratio (INR)

    Change from baseline in international normalized ratio in the blood (INR) (ratio)

    Measured: Weeks 0, 6, 14, 26

  32. Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)

    Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)

    Measured: Weeks 0, 6, 14, 26

  33. Change From Baseline in Interleukin-6

    Change from baseline in Interleukin-6 in the blood (ng/L)

    Measured: Weeks 0, 6, 14, 26

  34. Change From Baseline in Interleukin-10

    Change from baseline in Interleukin-10 in the blood (ng/L)

    Measured: Weeks 0, 6, 14, 26

  35. Change From Baseline in C-Reactive Protein

    Change from baseline in C-Reactive Protein in the blood (mg/dL)

    Measured: Weeks 0, 6, 14, 26

  36. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning

    Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  37. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health

    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.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  38. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems

    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.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  39. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue

    Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  40. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being

    Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  41. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning

    Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  42. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain

    Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  43. Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health

    Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

  44. Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score

    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

    Measured: Weeks 0, 2, 6, 10, 14, 18, 22, 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start20 Apr 2020
  3. Primary completion25 Nov 2020
  4. Study completion25 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04349631
Sponsor's protocol ID
HBCOVID01
Status last verified
Sep 2025
First submitted
6 Apr 2020
Last updated
26 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HB-adMSCs in people with COVID-19, run by Hope Biosciences Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Hospitalization for COVID-19 (time frame: Week 0 through Week 26 (End of Study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04349631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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