Incidence of Hospitalization for COVID-19
Primary
· Week 0 through Week 26 (End of Study)
Number of subjects that require hospitalization for COVID-19
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0 |
Last reviewed · How we verify
NCT04349631
A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19
Completed
Phase 2
Results posted
Last updated 26 September 2025
What this trial tests
Phase 2 trial testing HB-adMSCs in COVID-19 in 51 participants. Completed in 25 November 2020.
Timeline
20 April 2020
Primary endpoint
25 November 2020
25 November 2020
25 November 2020
Quick facts
| Lead sponsor | Hope Biosciences Research Foundation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 51 |
| Start date | 20 April 2020 |
| Primary completion | 25 November 2020 |
| Estimated completion | 25 November 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- HB-adMSCs — full drug profile →
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.
Incidence of Symptoms for COVID-19
Primary
· Week 0 through Week 26 (End of Study)
Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0 |
Absence of Upper/Lower Respiratory Infection
Secondary
· Week 0 through Week 26 (End of Study)
Absence of upper/lower respiratory infection (with hospitalization criteria)
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0 |
Change From Baseline in Glucose
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of glucose in the blood (mg/dL)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 96.4 | ± 16.11 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -4.1 | ± 18.00 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 5.8 | ± 21.07 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 6.8 | ± 40.90 |
Change From Baseline in Calcium
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of calcium in the blood (mg/dL)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 9.44 | ± 0.410 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.03 | ± 0.455 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.00 | ± 0.441 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.03 | ± 0.394 |
Change From Baseline in Albumin
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of albumin in the blood (g/dL)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 4.62 | ± 0.306 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.10 | ± 0.280 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.22 | ± 0.301 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.05 | ± 0.283 |
Change From Baseline in Total Protein
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of total protein in the blood (g/dL)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 6.89 | ± 0.469 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.04 | ± 0.394 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.11 | ± 0.500 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.02 | ± 0.428 |
Change From Baseline in Sodium
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of sodium in the blood (mmol/L)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 141.0 | ± 2.11 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.7 | ± 2.53 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -1.3 | ± 2.17 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -1.4 | ± 2.29 |
Change From Baseline in Total Carbon Dioxide
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of carbon dioxide in the blood (mmol/L)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 23.4 | ± 2.80 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.9 | ± 2.76 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.6 | ± 2.68 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.1 | ± 2.92 |
Change From Baseline in Potassium
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of potassium in the blood (mmol/L)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 4.31 | ± 0.364 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.21 | ± 0.409 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.16 | ± 0.369 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.10 | ± 0.415 |
Change From Baseline in Chloride
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of chloride in the blood (mmol/L)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 102.0 | ± 2.73 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.7 | ± 2.82 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.1 | ± 2.39 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.4 | ± 2.37 |
Change From Baseline in Blood Urea Nitrogen (BUN)
Secondary
· Weeks 0, 6, 14, 26
Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)
Week 0
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 15.0 | ± 4.21 |
Week 6
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -1.0 | ± 3.22 |
Week 14
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | 0.5 | ± 3.67 |
Week 26
| Group | Value | 95% CI |
|---|---|---|
| HB-adMSCs | -0.7 | ± 3.61 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Week 0 (Infusion 1) through Week 26 (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: 3/51 (6%)
Deaths: 0/51
Serious adverse events (3 terms)
| Reaction | System | HB-adMSCs |
|---|---|---|
| Urinary tract infection | Infections and infestations | — |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | — |
| Embolism | Vascular disorders | — |
Other adverse events (42 terms — click to expand)
| Reaction | System | HB-adMSCs |
|---|---|---|
| Headache | Nervous system disorders | — |
| Influenza like illness | General disorders | — |
| Fatigue | General disorders | — |
| Pyrexia | General disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vision blurred | Eye disorders | — |
| Chills | General disorders | — |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | — |
| COVID-19 | Infections and infestations | — |
| Palpitations | Cardiac disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Chest pain | General disorders | — |
| Oedema peripheral | General disorders | — |
| Balance disorder | Nervous system disorders | — |
| Dizziness | Nervous system disorders | — |
| Migraine with aura | Nervous system disorders | — |
| Paresthesia | Nervous system disorders | — |
| Sinus headache | Nervous system disorders | — |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — |
| Bursitis | Musculoskeletal and connective tissue disorders | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — |
| Crohn's disease | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Gastric dilatation | Gastrointestinal disorders | — |
| Herpes zoster | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Arrhythmia | Cardiac disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Foot fracture | Injury, poisoning and procedural complications | — |
| Muscle strain | Injury, poisoning and procedural complications | — |
| Blood bicarbonate decreased | Investigations | — |
| Colonoscopy | Investigations | — |
| SARS-CoV-2 antibody test positive | Investigations | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Insomnia | Psychiatric disorders | — |
Most-reported serious reactions: Urinary tract infection, Rheumatoid arthritis, Embolism.
Data from ClinicalTrials.gov NCT04349631 adverse events section.
Sponsor's own description
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.
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 -
Immunomodulatory Mechanisms of Mesenchymal Stem Cells and Their Potential Clinical Applications.
Huang Y, Wu Q, Tam PKH. · · 2022 · cited 143× · PMID 36077421 · DOI 10.3390/ijms231710023 -
Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells and Their Contribution to Angiogenic Processes in Tissue Regeneration.
Krawczenko A, Klimczak A. · · 2022 · cited 64× · PMID 35269568 · DOI 10.3390/ijms23052425 -
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 -
The role of mesenchymal stromal cells in immune modulation of COVID-19: focus on cytokine storm.
Kavianpour M, Saleh M, Verdi J. · · 2020 · cited 47× · PMID 32948252 · DOI 10.1186/s13287-020-01849-7 -
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 -
The Potential Use of Mesenchymal Stem Cells and Their Derived Exosomes as Immunomodulatory Agents for COVID-19 Patients.
Alzahrani FA, Saadeldin IM, Ahmad A, Kumar D, et al · · 2020 · cited 42× · PMID 33014070 · DOI 10.1155/2020/8835986
Verify or expand the search:
- PubMed search for NCT04349631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT04348435 — A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19. · Phase 2 · completed
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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
- NCT04362189 — Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 · Phase 2 · terminated
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 NCT04349631 (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/NCT04349631.
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