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COVID-19Phase 2NCT04362189

Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19
What is being tested?
HB-adMSC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
2 sitesUnited States
Study dates
30 Jun 2020to 30 Sep 2021
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
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Men, and women, over 18 years of age inclusively.
  • Patient is suspected to have COVID-19 infection.
  • Provides consent or consent is given by their legally authorized representative (LAR).
  • Agrees to the collection of venous blood per protocol.
  • Women of childbearing potential (WOCBP) and men (if their sexual partners are WOCBP) must use at least 1 highly effective form of birth control throughout the study and for 6 months after the last dose of study treatment. Highly effective methods of birth control include true sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk, in line with the preferred and usual lifestyle of the patient), surgery (bilateral tubal ligation or occlusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive associated with inhibition of ovulation (oral, patch, injectable, implantable, or intravaginal), intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

Who cannot join

  • Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. Absence of pregnancy will be confirmed through urine pregnancy test.
  • Patients who have participated or are participating in a clinical trial of an experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days.
  • Inability to provide informed consent or to comply with study requirements.
  • Patients with the following concomitant or past medical history:
  • Both Hypertension and Diabetes Mellitus.
  • Both Hypertension and Chronic Kidney Disease.
Show all 12Show fewer
  • Both Diabetes Mellitus and Chronic Kidney Disease.
  • History or evidence of alcohol abuse.
  • History or evidence of consumption of illicit drugs.
  • Patients requiring mechanical ventilation.
  • Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
  • Any medical disease or condition that, in the opinion of the site Principal Investigator 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • River Oaks Hospital and Clinics

    Houston, Texas, 77027

  • United Memorial Medical Center

    Houston, Texas, 77091

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.

Read the detailed description

This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.

Conditions
COVID-19
Being tested
HB-adMSC, Placebo
Keywords
Coronavirus, Stem cells, Mesenchymal stem cells, Adipose-derived mesenchymal stem cells, MSCs, COVID, SARS-CoV-2, Coronavirus disease
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-adMSCBiological

    Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

  • PlaceboOther

    Saline

Study groups in NCT04362189
Study groupRoleWhat they receive
HB-adMSCsExperimentalSubjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
Receives: Biological: HB-adMSC
PlaceboPlacebo comparatorSubjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Receives: Other: Placebo

What is being measured

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

  1. Tumor Necrosis Factor-Alpha (TNF-alpha)

    Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)

    Measured: Day 0, 3, 7, and 10

  2. Interleukin-10 (IL-10)

    Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)

    Measured: Day 0, 3, 7, and 10

  3. Interleukin-6 (IL-6)

    Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)

    Measured: Day 0, 3, 7, and 10

  4. C-Reactive Protein (CRP)

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

    Measured: Day 0, 3, 7, and 10

  5. Oxygenation

    Change from baseline Oxygenation (%) in the blood

    Measured: Day 0, 3, 7, and 10

  6. Return To Room Air (RTRA)

    Number of participants who returned to room air

    Measured: Day 0, 3, 7, and 10

Secondary outcomes (52)

  1. D-dimer

    Change from baseline in D-dimer in the blood (mg/L)

    Measured: Day 0, 3, 7, and Day 10

  2. Myoglobin

    Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)

    Measured: Day 0, 3 7, and 10

  3. Troponin

    Clinical lab evaluation of level of Troponin in the blood (ng/mL)

    Measured: Day 0, 3, 7, and 10

  4. Creatinine Kinase MB (CK-MB)

    Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)

    Measured: Day 0, 3, 7, and 10

  5. Serum Ferritin

    Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)

    Measured: Day 0, 3, 7, and 10

  6. NK Cell Surface Antigen (CD3-CD56+)

    Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)

    Measured: Day 0, 3, 7, and 10

  7. CD4+/CD8+ Ratio

    Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood

    Measured: Day 0, 3, 7, and 10

  8. 7-Point Ordinal Scale

    Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities.

    Measured: Day 0, 3, 7, 10, and 28 (End of Study)

  9. Computed Tomography (CT) Score

    Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.

    Measured: Day 0 and Day 28

  10. Chest X-Ray Score

    Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.

    Measured: Day 0, Day 28

  11. Glucose

    Clinical lab evaluation of level of Glucose in the blood (mg/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  12. Blood Urea Nitrogen (BUN)

    Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  13. Estimated Glomerular Filtration Rate (eGFR) if Non-African American

    Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73)

    Measured: Screening, Day 0, 3, 7, and 10

  14. Estimated Glomerular Filtration Rate (eGFR) if African American

    Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)

    Measured: Screening, Day 0, 3, 7, and 10

  15. BUN/Creatinine Ratio

    Clinical lab evaluation of BUN/Creatinine Ratio in the blood

    Measured: Screening, Day 0, 3, 7, and 10

  16. Sodium

    Clinical lab evaluation of level of Sodium in the blood (mmol/L)

    Measured: Screening, Day 0, 3, 7, and 10

  17. Potassium

    Clinical lab evaluation of level of Potassium in the blood (mmol/L)

    Measured: Screening, Day 0, 3, 7, and 10

  18. Chloride

    Clinical lab evaluation of level of Chloride in the blood (mmol/L)

    Measured: Screening, Day 0, 3, 7, and 10

  19. Carbon Dioxide Total

    Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)

    Measured: Screening, Day 0, 3, 7, and 10

  20. Calcium

    Clinical lab evaluation of level of Calcium in the blood (mg/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  21. Protein Total

    Clinical lab evaluation of total level of Protein in the blood (g/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  22. Albumin

    Clinical lab evaluation of level of Albumin in the blood (g/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  23. Globulin Total

    Clinical lab evaluation of the total level of Globulin in the blood (g/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  24. Albumin/Globulin (A/G) Ratio

    Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood

    Measured: Screening, Day 0, 3, 7, and 10

  25. Bilirubin Total

    Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  26. Alkaline Phosphatase

    Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)

    Measured: Screening, Day 0, 3, 7, and 10

  27. Aspartate Aminotransferase (SGOT)

    Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)

    Measured: Screening, Day 0, 3, 7, and 10

  28. Alanine Aminotransferase (SGPT)

    Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)

    Measured: Screening, Day 0, 3, 7, and 10

  29. White Blood Count (WBC)

    Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  30. Red Blood Cell (RBC) Count

    Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  31. Hemoglobin

    Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  32. Hematocrit

    Clinical lab evaluation of level of Hematocrit in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  33. Mean Corpuscular Volume (MCV)

    Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)

    Measured: Screening, Day 0, 3, 7, and 10

  34. Mean Corpuscular Hemoglobin (MCH)

    Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)

    Measured: Screening, Day 0, 3, 7, and 10

  35. Mean Corpuscular Hemoglobin Concentration (MCHC)

    Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)

    Measured: Screening, Day 0, 3, 7, and 10

  36. Red Cell Distribution Width (RDW)

    Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  37. Platelets

    Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  38. Neutrophils

    Clinical lab evaluation of level of Neutrophils in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  39. Lymphocytes

    Clinical lab evaluation of level of Lymphocytes in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  40. Monocytes

    Clinical lab evaluation of level of Monocytes in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  41. Eosinophils

    Clinical lab evaluation of level of Eosinophils n the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  42. Basophils

    Clinical lab evaluation of level of Basophils in the blood (%)

    Measured: Screening, Day 0, 3, 7 and 10

  43. Absolute Neutrophils

    Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  44. Absolute Lymphocytes

    Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  45. Absolute Monocytes

    Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  46. Absolute Eosinophils

    Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  47. Absolute Basophils

    Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  48. Immature Granulocytes

    Clinical lab evaluation of level of Immature Granulocytes in the blood (%)

    Measured: Screening, Day 0, 3, 7, and 10

  49. Absolute Immature Granulocytes

    Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL)

    Measured: Screening, Day 0, 3, 7, and 10

  50. International Normalized Ratio (INR)

    Clinical lab evaluation of International Normalized Ratio (INR)

    Measured: Screening, Day 0, 3, 7, and 10

  51. Prothrombin Time (PT)

    Clinical lab evaluation of Prothrombin Time (seconds)

    Measured: Screening, Day 0, 3, 7, and 10

  52. Partial Thromboplastin Time (PTT)

    Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)

    Measured: Screening, Day 0, 3, 7, and 10

Timeline

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

  1. First posted24 Apr 2020
  2. Study start30 Jun 2020
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Why it stopped: No need to continue with the availability of the COVID-19 VACCINE

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04362189
Sponsor's protocol ID
HBCOV03
Status last verified
Sep 2025
First submitted
21 Apr 2020
Last updated
26 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Dios C, Vij R, Kim H, Park H, Chang D. Safety of multiple intravenous infusions of adipose-derived mesenchymal stem cells for hospitalized cases of COVID-19: a randomized controlled trial. Front Med (Lausanne). 2023 Dec 22;10:1321303. doi: 10.3389/fmed.2023.1321303. eCollection 2023.

    PubMed 38188343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HB-adMSC in people with COVID-19, run by Hope Biosciences Research Foundation at 2 sites 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 5 inclusion and 12 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: stopped early, 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 2 sites 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. Some participants in this study may receive a placebo. 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 25 Jul 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?

Tumor Necrosis Factor-Alpha (TNF-alpha) (time frame: Day 0, 3, 7, and 10). The study lists 6 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 NCT04362189, which also lists 1 linked publication.

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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