NCT04362189 is a Phase 2 clinical trial of HB-adMSC in COVID-19, sponsored by Hope Biosciences Research Foundation.

Who is sponsoring NCT04362189?

NCT04362189 is sponsored by Hope Biosciences Research Foundation.

What drugs are being tested in NCT04362189?

Interventions in NCT04362189: HB-adMSC, Placebo.

Is NCT04362189 still recruiting?

NCT04362189 is currently terminated. Last updated 26 September 2025.

Are results published for NCT04362189?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-26 · How we verify

NCT04362189

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 26 September 2025

What this trial tests

Phase 2 trial testing HB-adMSC in COVID-19 in 48 participants. Terminated before completion.

Timeline

30 June 2020

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Hope Biosciences Research Foundation
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	30 June 2020
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	2 locations across United States

Drugs / interventions tested

HB-adMSC — full drug profile →
Placebo

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Hope Biosciences Research Foundation

Who can join

Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tumor Necrosis Factor-Alpha (TNF-alpha) Primary · Day 0, 3, 7, and 10

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

Day 0 (Baseline)

Group	Value	95% CI
HB-adMSCs	15.5	± 13.9
Placebo	18.2	± 12.3

Day 3

Group	Value	95% CI
HB-adMSCs	26.1	± 26.5
Placebo	15.9	± 10.0

Day 7

Group	Value	95% CI
HB-adMSCs	33.4	± 49.8
Placebo	35.3	± 38.8

Day 10

Group	Value	95% CI
HB-adMSCs	20.3	± 11.3
Placebo	30.5	± 40.5

Interleukin-10 (IL-10) Primary · Day 0, 3, 7, and 10

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

Day 0 (Baseline)

Group	Value	95% CI
HB-adMSCs	16.3	± 19.4
Placebo	11.9	± 16.6

Day 3

Group	Value	95% CI
HB-adMSCs	18.8	± 39.1
Placebo	44.7	± 98.9

Day 7

Group	Value	95% CI
HB-adMSCs	30.8	± 86.3
Placebo	27.2	± 65.1

Day 10

Group	Value	95% CI
HB-adMSCs	13.0	± 13.5
Placebo	8.4	± 10.8

Interleukin-6 (IL-6) Primary · Day 0, 3, 7, and 10

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

Day 0 (Baseline)

Group	Value	95% CI
HB-adMSCs	24.3	± 71.8
Placebo	69.4	± 166.5

Day 3

Group	Value	95% CI
HB-adMSCs	46.3	± 104.0
Placebo	376.6	± 988.7

Day 7

Group	Value	95% CI
HB-adMSCs	65.4	± 186.8
Placebo	197.8	± 539.7

Day 10

Group	Value	95% CI
HB-adMSCs	35.0	± 70.4
Placebo	12.4	± 23.9

C-Reactive Protein (CRP) Primary · Day 0, 3, 7, and 10

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

Day 0 (Baseline)

Group	Value	95% CI
HB-adMSCs	4.9	± 5.8
Placebo	3.8	± 5.1

Day 3

Group	Value	95% CI
HB-adMSCs	4.8	± 7.5
Placebo	4.5	± 9.2

Day 7

Group	Value	95% CI
HB-adMSCs	3.6	± 3.4
Placebo	2.2	± 4.1

Day 10

Group	Value	95% CI
HB-adMSCs	3.5	± 4.8
Placebo	0.2	± 0.2

Oxygenation Primary · Day 0, 3, 7, and 10

Change from baseline Oxygenation (%) in the blood

Day 0 (Baseline)

Group	Value	95% CI
HB-adMSCs	95.3	± 3.1
Placebo	89.4	± 19.1

Day 3

Group	Value	95% CI
HB-adMSCs	95.4	± 3.2
Placebo	94.5	± 4.7

Day 7

Group	Value	95% CI
HB-adMSCs	96.2	± 2.2
Placebo	95.8	± 5.7

Day 10

Group	Value	95% CI
HB-adMSCs	96.7	± 2.5
Placebo	96.7	± 1.7

Return To Room Air (RTRA) Primary · Day 0, 3, 7, and 10

Number of participants who returned to room air

Day 0

Group	Value	95% CI
HB-adMSCs	15
Placebo	4

Day 3

Group	Value	95% CI
HB-adMSCs	13
Placebo	8

Day 7

Group	Value	95% CI
HB-adMSCs	11
Placebo	7

Day 10

Group	Value	95% CI
HB-adMSCs	12
Placebo	8

D-dimer Secondary · Day 0, 3, 7, and Day 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	1.3	± 1.4
Placebo	2.1	± 2.6

Day 3

Group	Value	95% CI
HB-adMSCs	1.2	± 1.7
Placebo	2.3	± 2.8

Day 7

Group	Value	95% CI
HB-adMSCs	0.7	± 0.5
Placebo	13.6	± 9.1

Day 10

Group	Value	95% CI
HB-adMSCs	6.8	± 7.7

Myoglobin Secondary · Day 0, 3 7, and 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	183.0	± NA
Placebo	21.0	± NA

Day 3

Group	Value	95% CI
HB-adMSCs	142.3	± 155.8
Placebo	100.0	± NA

Day 7

Group	Value	95% CI
HB-adMSCs	21.5	± 0.7

Day 10

Group	Value	95% CI
HB-adMSCs	50.3	± 48.2

Troponin Secondary · Day 0, 3, 7, and 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	0.5	± 1.8
Placebo	0.0	± 0.0

Day 3

Group	Value	95% CI
HB-adMSCs	0.0	± 0.0
Placebo	0.0

Day 7

Group	Value	95% CI
HB-adMSCs	0.1	± 0.2
Placebo	0.0

Day 10

Group	Value	95% CI
HB-adMSCs	0.0	± 0.0

Creatinine Kinase MB (CK-MB) Secondary · Day 0, 3, 7, and 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	2.6	± 2.6
Placebo	2.0	± 1.1

Day 3

Group	Value	95% CI
HB-adMSCs	3.0	± 4.6
Placebo	2.2	± 1.2

Day 7

Group	Value	95% CI
HB-adMSCs	3.3	± 2.9
Placebo	2.3	± 1.4

Day 10

Group	Value	95% CI
HB-adMSCs	3.7	± 3.9
Placebo	1.9

Serum Ferritin Secondary · Day 0, 3, 7, and 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	420.5	± 406.0
Placebo	423.5	± 387.9

Day 3

Group	Value	95% CI
HB-adMSCs	499.6	± 424.2
Placebo	391.2	± 324.0

Day 7

Group	Value	95% CI
HB-adMSCs	753.9	± 449.4
Placebo	361.0	± 397.8

Day 10

Group	Value	95% CI
HB-adMSCs	509.0	± 384.9
Placebo	63.2

NK Cell Surface Antigen (CD3-CD56+) Secondary · Day 0, 3, 7, and 10

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

Day 0

Group	Value	95% CI
HB-adMSCs	66.4	± 58.5
Placebo	6.9

Day 3

Group	Value	95% CI
Placebo	320.0

Day 7

Group	Value	95% CI
HB-adMSCs	21.9	± 30.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening through Day 28 (End of Study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HB-adMSCs

Serious: 9/33 (27%)

Deaths: 8/33

Placebo

Serious: 2/15 (13%)

Deaths: 2/15

Serious adverse events (5 terms)

Reaction	System	HB-adMSCs	Placebo
Cardiopulmonary Failure	Cardiac disorders	—	—
Sepsis	Infections and infestations	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—
Cardiac Arrhythmia	Cardiac disorders	—	—

Other adverse events (42 terms — click to expand)

Reaction	System	HB-adMSCs	Placebo
Body Aches	Musculoskeletal and connective tissue disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hyperthermia	Nervous system disorders	—	—
Fatigue	Nervous system disorders	—	—
Anxiety	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Hypertension	Cardiac disorders	—	—
Chest Discomfort	Cardiac disorders	—	—
Agitation	Nervous system disorders	—	—
Confusional State	Nervous system disorders	—	—
Chills	Nervous system disorders	—	—
Vesicular Rash	Skin and subcutaneous tissue disorders	—	—
Bradycardia	Cardiac disorders	—	—
Nausea	Nervous system disorders	—	—
Painful Respiration	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Pancreatitis	Endocrine disorders	—	—
Poor Venous Access	Vascular disorders	—	—
ESR Raised	Blood and lymphatic system disorders	—	—
Myofascial Neck Pain	Musculoskeletal and connective tissue disorders	—	—
Brain Natriuretic Peptide Increased	Nervous system disorders	—	—
Carbon Dioxide Abnormal	Blood and lymphatic system disorders	—	—
Hyperglycemia	Blood and lymphatic system disorders	—	—
Urine Abnormality	Renal and urinary disorders	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—
Myocardial Necrosis Marker Increased	Cardiac disorders	—	—
Abnormal Blood Electrolytes	Blood and lymphatic system disorders	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—
Elevated WBC	Blood and lymphatic system disorders	—	—
Dry Throat	Respiratory, thoracic and mediastinal disorders	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Feeling Abnormal	Nervous system disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Depression	Psychiatric disorders	—	—
Kidney Failure	Renal and urinary disorders	—	—
Hypotension	Cardiac disorders	—	—

Most-reported serious reactions: Cardiopulmonary Failure, Sepsis, Respiratory Failure, Coagulopathy, Cardiac Arrhythmia.

Data from ClinicalTrials.gov NCT04362189 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Challenges and advances in clinical applications of mesenchymal stromal cells.
Zhou T, Yuan Z, Weng J, Pei D, et al · · 2021 · cited 489× · PMID 33579329 · DOI 10.1186/s13045-021-01037-x
Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.
Singh B, Ryan H, Kredo T, Chaplin M, et al · · 2021 · cited 140× · PMID 33624299 · DOI 10.1002/14651858.cd013587.pub2
Mesenchymal stem cells and exosome therapy for COVID-19: current status and future perspective.
Gupta A, Kashte S, Gupta M, Rodriguez HC, et al · · 2020 · cited 55× · PMID 32780299 · DOI 10.1007/s13577-020-00407-w
Potential application of mesenchymal stem cells and their exosomes in lung injury: an emerging therapeutic option for COVID-19 patients.
Al-Khawaga S, Abdelalim EM. · · 2020 · cited 54× · PMID 33059757 · DOI 10.1186/s13287-020-01963-6
Widely available lysosome targeting agents should be considered as potential therapy for COVID-19.
Homolak J, Kodvanj I. · · 2020 · cited 54× · PMID 32522674 · DOI 10.1016/j.ijantimicag.2020.106044
Research progress on Mesenchymal Stem Cells (MSCs), Adipose-Derived Mesenchymal Stem Cells (AD-MSCs), Drugs, and Vaccines in Inhibiting COVID-19 Disease.
Gentile P, Sterodimas A, Pizzicannella J, Calabrese C, et al · · 2020 · cited 52× · PMID 33014532 · DOI 10.14336/ad.2020.0711
Mesenchymal stem cell therapies for COVID-19: Current status and mechanism of action.
Sadeghi S, Soudi S, Shafiee A, Hashemi SM. · · 2020 · cited 43× · PMID 32979360 · DOI 10.1016/j.lfs.2020.118493

Verify or expand the search:

Other trials of HB-adMSC

Trials testing the same drug.

NCT04604288 — Individual Patient Expanded Access IND of Autologous HB-adMSCS for the Treatment of Bilateral Knee Pain. · no longer available
NCT04711811 — Individual Patient Expanded Access IND of HB-adMSCs for Chronic Musculoskeletal Pain. · no longer available

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Hope Biosciences Research Foundation trials

Trials by the same sponsor.

NCT05126563 — Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome · Phase 2 · completed
NCT05116540 — Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis · Phase 2 · completed
NCT04995081 — Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD) · Phase 2 · completed
NCT04928287 — Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) · Phase 2 · completed
NCT04348435 — A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04362189 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hope Biosciences Research Foundation
Last refreshed: 26 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04362189.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04362189

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of HB-adMSC

Other recruiting trials for COVID-19

Other Hope Biosciences Research Foundation trials

Verify against primary sources