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COVID-19Phase 2NCT04348435

A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs 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 allogeneic 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?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteUnited States
Study dates
14 May 2020to 12 May 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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Men, and women 18 years of age or older
  • Participant works in a capacity that is characterized as high-risk or very high-risk
  • High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19.
  • First responders, health care delivery and support staff (e.g., law enforcement, fire fighters, paramedics, doctors, nurses, and other hospital staff who must enter patients' rooms) exposed to individuals potentially having COVID-19.
  • Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
  • Very High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem or laboratory procedures.
Show all 12Show fewer
  • Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical technicians) performing aerosol-generating procedures (e.g., intubation, cough induction procedures, bronchoscopies, some dental procedures and exams or invasive specimen collection) on known or suspected COVID-19 patients.
  • Health care or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients (e.g., manipulating cultures from known or suspected COVID-19 patients).
  • Morgue workers performing autopsies, which generally involve aerosol-generating procedures, on the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death
  • No signs or symptoms of infection, including but not limited to, body temperature >100 F and pulse rate > 100 BPM.
  • 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

  • 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.

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 Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess Efficacy and Safety of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19.

Hope Biosciences is conducting a research study of an investigational product called allogeneic 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, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of subjects that develop symptoms of COVID-19. 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, Placebos
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

    Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

  • PlacebosOther

    Saline

Study groups in NCT04348435
Study groupRoleWhat they receive
Allogeneic HB-adMSCs 200MMExperimentalSubjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Receives: Biological: HB-adMSCs
Allogeneic HB-adMSCs 100MMExperimentalSubjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Receives: Biological: HB-adMSCs
Allogeneic HB-adMSCs 50MMExperimentalSubjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
Receives: Biological: HB-adMSCs
PlaceboPlacebo comparatorSubjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.
Receives: Other: Placebos

What is being measured

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

  1. Number of Participants That Were Hospitalized Due to COVID-19 Symptoms

    Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.

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

  2. Number of Participants That Had Symptoms Associated With COVID-19

    Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.

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

Secondary outcomes (7)

  1. Leukocyte Differential Count

    Change from baseline in Leukocyte Differential Count

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

  2. C Reactive Protein

    Change from baseline in C Reactive Protein

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

  3. Tumor Necrosis Factor - Alpha

    Change from baseline in TNF alpha

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

  4. Interleukin 6

    Change from baseline in IL-6

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

  5. Interleukin 10

    Change from baseline in IL-10

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

  6. Short Form-36 (SF-36)

    The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

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

  7. Patient Health Questionnaire (PHQ-9) Scores

    The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression.

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

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 start14 May 2020
  3. Primary completion12 May 2021
  4. Study completion12 May 2021

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04348435
Sponsor's protocol ID
HBCOV02
Status last verified
Sep 2025
First submitted
14 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 12 inclusion and 6 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. 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 17 Nov 2022). 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?

Number of Participants That Were Hospitalized Due to COVID-19 Symptoms (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 NCT04348435.

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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Clinical Trial NCT04348435 | AzTrials