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CompletedNCT04348435Updated Sep 26, 2025Results posted

A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.

A Phase 2 interventional study of HB-adMSCs and Placebos in COVID-19, sponsored by Hope Biosciences Research Foundation. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by Hope Biosciences Research Foundation · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COVID-19

Keywords

  • Coronavirus
  • Prevention
  • Immune support
  • stem cells
  • mesenchymal stem cells
  • adipose-derived mesenchymal stem cells
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 53 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hope Biosciences Research Foundation is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Allogeneic HB-adMSCs 200MM

    Subjects 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.

    Biological: HB-adMSCs

  • Experimental
    Allogeneic HB-adMSCs 100MM

    Subjects 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.

    Biological: HB-adMSCs

  • Experimental
    Allogeneic HB-adMSCs 50MM

    Subjects 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.

    Biological: HB-adMSCs

  • Placebo comparator
    Placebo

    Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.

    Other: Placebos

Interventions

  • BiologicalHB-adMSCs

    Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

  • OtherPlacebos

    Saline

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  1. Leukocyte Differential Count

    Change from baseline in Leukocyte Differential Count

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

  2. C Reactive Protein

    Change from baseline in C Reactive Protein

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

  3. Tumor Necrosis Factor - Alpha

    Change from baseline in TNF alpha

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

  4. Interleukin 6

    Change from baseline in IL-6

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

  5. Interleukin 10

    Change from baseline in IL-10

    Time frame: 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.

    Time frame: 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.

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

07

Results

Posted Nov 17, 2022

Participant flow

Selection of subjects was based on the inclusion and exclusion criteria and only those subjects who met all of the inclusion criteria and none of the exclusion criteria, were eligible to participate in the trial. The first participant was enrolled on 05/14/2020 and the last participant was enrolled on 11/04/2020.

Participant flow — Overall Study
MilestoneAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
Started1991213
Completed115910
Not completed8433

Outcome measures

PrimaryNumber 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.

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Count of participants · Participants
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms
ParticipantsAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
Number of Subjects that were Hospitalized due to COVID-19 Symptoms0000
Number of Subjects that were not Hospitalized due to COVID-19 Symptoms135109
PrimaryNumber 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.

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Count of participants · Participants
Number of Participants That Had Symptoms Associated With COVID-19
ParticipantsAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
Number of Subjects with Incidence of COVID-19 Symptoms4000
Number of Subjects with No Incidence of COVID-19 Symptoms95109
SecondaryLeukocyte Differential Count

Change from baseline in Leukocyte Differential Count

Time frame:
Week 0 to Week 26 (End of Study)
Reported as:
Least squares mean · Leukocytes (x10^9/L)
Leukocyte Differential Count
Leukocytes (x10^9/L)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans6.204 ± 0.2965.518 ± 0.5026.029 ± 0.3935.951 ± 0.392
Change from baseline0.508 ± 0.296-0.179 ± 0.5020.333 ± 0.3930.255 ± 0.392
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.6113 · Mean difference (net): 0.253
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.5039 · Mean difference (net): -0.434
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.8903 · Mean difference (net): 0.077
SecondaryC Reactive Protein

Change from baseline in C Reactive Protein

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Least squares mean · mg/L
C Reactive Protein
mg/LAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans2.424 ± 0.6321.759 ± 1.0472.679 ± 0.8462.671 ± 0.843
Change from baseline-0.609 ± 0.632-1.275 ± 1.047-0.354 ± 0.846-0.362 ± 0.843
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.8171 · Mean difference (net): -0.247
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.5034 · Mean difference (net): -0.913
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.9948 · Mean difference (net): 0.008
SecondaryTumor Necrosis Factor - Alpha

Change from baseline in TNF alpha

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Least squares mean · ng/L
Tumor Necrosis Factor - Alpha
ng/LAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans1.175 ± 0.0910.951 ± 0.1501.173 ± 0.1230.996 ± 0.124
Change from baseline-0.316 ± 0.091-0.540 ± 0.150-0.318 ± 0.123-0.495 ± 0.124
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.2641 · Mean difference (net): 0.179
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.8220 · Mean difference (net): -0.045
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.3097 · Median difference (net): 0.178
SecondaryInterleukin 6

Change from baseline in IL-6

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Least squares mean · ng/L
Interleukin 6
ng/LAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans1.620 ± 0.0401.620 ± 0.0651.732 ± 0.0531.620 ± 0.056
Change from baseline-0.019 ± 0.040-0.019 ± 0.0650.092 ± 0.053-0.019 ± 0.056
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 1.000 · Mean difference (net): 0.000
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 1.000 · Mean difference (net): 0.000
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.1713 · Mean difference (net): 0.112
SecondaryInterleukin 10

Change from baseline in IL-10

Time frame:
Week 0 through Week 26 (End of Study)
Reported as:
Least squares mean · ng/L
Interleukin 10
ng/LAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans0.768 ± 0.0540.680 ± 0.0890.680 ± 0.0730.688 ± 0.073
Change from baseline0.088 ± 0.0540.000 ± 0.0890.000 ± 0.0730.008 ± 0.073
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.3868 · Mean difference (net): 0.080
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.9429 · Mean difference (net): -0.008
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.9362 · Mean difference (net): -0.008
SecondaryShort 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.

Time frame:
Week 0 to Week 26 (End of Study)
Reported as:
Least squares mean · Score on a Scale
Short Form-36 (SF-36)
Score on a ScaleAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
Average Energy/Fatigue68.858 ± 5.13978.346 ± 7.67275.849 ± 5.12569.567 ± 5.826
Average Energy/Fatigue - Change from baseline7.140 ± 5.13916.628 ± 7.67214.130 ± 5.1257.848 ± 5.826
Average Social Functioning98.950 ± 2.19090.711 ± 3.55699.864 ± 2.50398.430 ± 2.484
Average Social Functioning - Change from baseline7.153 ± 2.190-1.086 ± 3.5568.067 ± 2.5036.633 ± 2.484
Avg. Role Limitations Due to Physical Health94.711 ± 2.326100.00 ± 4.39398.727 ± 2.58798.831 ± 2.737
Avg. Role Limitations Due to Physical Health - Change from baseline1.742 ± 2.32614.280 ± 4.3935.758 ± 2.5875.862 ± 2.737
Average General Health76.481 ± 3.81878.857 ± 6.27481.016 ± 4.19675.518 ± 4.454
Average General Health - Change from baseline1.481 ± 3.8183.857 ± 6.2746.016 ± 4.1960.518 ± 4.454
Average Physical Functioning92.361 ± 2.66096.806 ± 4.42093.598 ± 2.93989.928 ± 3.123
Average Physical Functioning - Change from baseline1.267 ± 2.6605.712 ± 4.4202.504 ± 2.939-1.166 ± 3.123
Average Pain90.744 ± 3.74684.700 ± 6.29191.166 ± 4.12479.065 ± 4.377
Average Pain - Change from baseline11.212 ± 3.7465.169 ± 6.29111.635 ± 4.124-0.466 ± 4.377
Average Emotional Well Being87.057 ± 2.56688.413 ± 4.09686.992 ± 2.73984.724 ± 2.863
Average Emotional Well Being - Change from baseline4.057 ± 2.5665.413 ± 4.0963.992 ± 2.7391.724 ± 2.863
Avg. Role Limitations Due to Emotional Problems99.667 ± 2.33497.000 ± 3.65497.000 ± 2.45697.000 ± 2.601
Avg. Role Limitations Due to Emotional Problems - Change from baseline3.833 ± 2.3341.166 ± 3.6541.166 ± 2.4561.166 ± 2.601
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.9333 · Mean difference (net): -0.708
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.3627 · Mean difference (net): 8.780
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.4160 · Mean difference (net): 6.282
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.8768 · Mean difference (net): 0.520
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.0869 · Mean difference (net): -7.719
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.6864 · Mean difference (net): 1.434
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.2587 · Mean difference (net): -4.120
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.1250 · Mean difference (net): 8.417
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.9780 · Mean difference (net): -0.104
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.8721 · Mean difference (net): 0.963
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.6694 · Mean difference (net): 3.340
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.3733 · Mean difference (net): 5.498
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.5594 · Mean difference (net): 2.433
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.2127 · Mean difference (net): 6.878
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.4012 · Mean difference (net): 3.670
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.0521 · Mean difference (net): 11.678
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.4704 · Mean difference (net): 5.635
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.0544 · Mean difference (net): 12.101
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.5535 · Mean difference (net): 2.333
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.4642 · Mean difference (net): 3.689
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.5692 · Mean difference (net): 2.268
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.4642 · Median difference (net): 2.667
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 1.0000 · Mean difference (net): 0.000
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 1.0000 · Mean difference (net): 0.000
SecondaryPatient 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.

Time frame:
Week 0 to Week 26 (End of Study)
Reported as:
Least squares mean · Score on a Scale
Patient Health Questionnaire (PHQ-9) Scores
Score on a ScaleAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
LSMeans1.373 ± 0.4890.912 ± 0.7631.114 ± 0.4561.517 ± 0.538
Change from baseline-1.111 ± 0.489-1.572 ± 0.763-1.370 ± 0.456-0.967 ± 0.538
Statistical analysis
  • Allogeneic HB-adMSCs 200MM vs Placebo · ANCOVA · p = 0.8628 · Mean difference (net): -0.144
  • Allogeneic HB-adMSCs 100MM vs Placebo · ANCOVA · p = 0.5257 · Mean difference (net): -0.605
  • Allogeneic HB-adMSCs 50MM vs Placebo · ANCOVA · p = 0.5467 · Mean difference (net): -0.403

Adverse events

Collected over Week 0 through Week 26 (End of Study). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Allogeneic HB-adMSCs 200MM0/19 (0%)0/19 (0%)15/19 (78.9%)
Allogeneic HB-adMSCs 100MM0/9 (0%)0/9 (0%)5/9 (55.6%)
Allogeneic HB-adMSCs 50MM0/12 (0%)0/12 (0%)7/12 (58.3%)
Placebo0/13 (0%)0/13 (0%)10/13 (76.9%)
Most frequent other events
Showing 10 of 36
Most frequent other events
EventAllogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlacebo
Muscle fatigueMusculoskeletal and connective tissue disorders2/191/92/127/13
Influenza like illnessGeneral disorders9/192/90/125/13
HeadacheNervous system disorders8/192/93/124/13
MyalgiaMusculoskeletal and connective tissue disorders3/191/91/120/13
ArthralgiaMusculoskeletal and connective tissue disorders0/191/90/122/13
Pain in extremityMusculoskeletal and connective tissue disorders0/191/90/120/13
DizzinessNervous system disorders1/191/90/120/13
FatigueGeneral disorders1/191/90/120/13
NauseaGastrointestinal disorders2/191/90/121/13
Blood pressure increasedInvestigations0/191/90/120/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Mean45.8 ± 13.3447.6 ± 9.6543.9 ± 12.3842.8 ± 9.9744.9 ± 11.58
Sex: Female, Male
Sex: Female, Male(Participants)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Female1057830
Male945523
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Hispanic or Latino322411
Not Hispanic or Latino16710942
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
American Indian or Alaska Native00000
Asian30328
Native Hawaiian or Other Pacific Islander00000
Black or African American31217
White13871038
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
United States199121353
Height
Height(cm)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Mean172.05 ± 10.18167.35 ± 11.60168.38 ± 8.70171.54 ± 11.66170.30 ± 10.39
Body Weight
Body Weight(kg)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Mean93.132 ± 29.1285.982 ± 26.7278.662 ± 14.6979.763 ± 23.5185.362 ± 24.84
BMI
BMI(kg/m^2)Allogeneic HB-adMSCs 200MMAllogeneic HB-adMSCs 100MMAllogeneic HB-adMSCs 50MMPlaceboTotal
Mean31.14 ± 8.42630.18 ± 6.27127.61 ± 3.94626.83 ± 6.60629.12 ± 6.893
08

Study locations

1 site
  • Hope Biosciences Stem Cell Research Foundation
    Sugar Land, Texas 77478, United States
09

References and documents

Study documents

  • Study protocol · Jan 29, 2021
  • Statistical analysis plan · Oct 14, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04348435
Lead sponsor
Hope Biosciences Research Foundation
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
May 14, 2020
Primary completion
May 12, 2021
Completion
May 12, 2021
Results posted
Nov 17, 2022
Last update
Sep 26, 2025

Study contacts

Thanh Cheng, MD
principal investigator · Hope Biosciences Stem Cell Research Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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