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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: HB-adMSC

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77091
      • United Memorial Medical Center
    • Houston, Texas, United States, 77027
      • River Oaks Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men, and women, over 18 years of age inclusively.
2. Patient is suspected to have COVID-19 infection.
3. Provides consent or consent is given by their legally authorized representative (LAR).
4. Agrees to the collection of venous blood per protocol.
5. 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).

Exclusion Criteria:

1. 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.
2. 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.
3. Inability to provide informed consent or to comply with study requirements.

4. Patients with the following concomitant or past medical history:

   • Both Hypertension and Diabetes Mellitus.
   • Both Hypertension and Chronic Kidney Disease.
   • Both Diabetes Mellitus and Chronic Kidney Disease.
5. History or evidence of alcohol abuse.
6. History or evidence of consumption of illicit drugs.
7. Patients requiring mechanical ventilation.
8. Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB-adMSCs; Subjects 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.	Biological: HB-adMSC; Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
Placebo Comparator: Placebo; Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.	Other: Placebo; Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Necrosis Factor-Alpha (TNF-alpha)	Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)	Day 0, 3, 7, and 10
Interleukin-10 (IL-10)	Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)	Day 0, 3, 7, and 10
Interleukin-6 (IL-6)	Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)	Day 0, 3, 7, and 10
C-Reactive Protein (CRP)	Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)	Day 0, 3, 7, and 10
Oxygenation	Change from baseline Oxygenation (%) in the blood	Day 0, 3, 7, and 10
Return To Room Air (RTRA)	Number of participants who returned to room air	Day 0, 3, 7, and 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-dimer	Change from baseline in D-dimer in the blood (mg/L)	Day 0, 3, 7, and Day 10
Myoglobin	Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)	Day 0, 3 7, and 10
Troponin	Clinical lab evaluation of level of Troponin in the blood (ng/mL)	Day 0, 3, 7, and 10
Creatinine Kinase MB (CK-MB)	Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)	Day 0, 3, 7, and 10
Serum Ferritin	Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)	Day 0, 3, 7, and 10
NK Cell Surface Antigen (CD3-CD56+)	Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)	Day 0, 3, 7, and 10
CD4+/CD8+ Ratio	Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood	Day 0, 3, 7, and 10
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.	Day 0, 3, 7, 10, and 28 (End of Study)
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.	Day 0 and Day 28
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.	Day 0, Day 28
Glucose	Clinical lab evaluation of level of Glucose in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Blood Urea Nitrogen (BUN)	Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)	Screening, Day 0, 3, 7, and 10
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)	Screening, Day 0, 3, 7, and 10
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)	Screening, Day 0, 3, 7, and 10
BUN/Creatinine Ratio	Clinical lab evaluation of BUN/Creatinine Ratio in the blood	Screening, Day 0, 3, 7, and 10
Sodium	Clinical lab evaluation of level of Sodium in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Potassium	Clinical lab evaluation of level of Potassium in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Chloride	Clinical lab evaluation of level of Chloride in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Carbon Dioxide Total	Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Calcium	Clinical lab evaluation of level of Calcium in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Protein Total	Clinical lab evaluation of total level of Protein in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Albumin	Clinical lab evaluation of level of Albumin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Globulin Total	Clinical lab evaluation of the total level of Globulin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Albumin/Globulin (A/G) Ratio	Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood	Screening, Day 0, 3, 7, and 10
Bilirubin Total	Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Alkaline Phosphatase	Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
Aspartate Aminotransferase (SGOT)	Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
Alanine Aminotransferase (SGPT)	Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
White Blood Count (WBC)	Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL)	Screening, Day 0, 3, 7, and 10
Red Blood Cell (RBC) Count	Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL)	Screening, Day 0, 3, 7, and 10
Hemoglobin	Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Hematocrit	Clinical lab evaluation of level of Hematocrit in the blood (%)	Screening, Day 0, 3, 7, and 10
Mean Corpuscular Volume (MCV)	Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)	Screening, Day 0, 3, 7, and 10
Mean Corpuscular Hemoglobin (MCH)	Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)	Screening, Day 0, 3, 7, and 10
Mean Corpuscular Hemoglobin Concentration (MCHC)	Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Red Cell Distribution Width (RDW)	Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)	Screening, Day 0, 3, 7, and 10
Platelets	Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Neutrophils	Clinical lab evaluation of level of Neutrophils in the blood (%)	Screening, Day 0, 3, 7, and 10
Lymphocytes	Clinical lab evaluation of level of Lymphocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Monocytes	Clinical lab evaluation of level of Monocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Eosinophils	Clinical lab evaluation of level of Eosinophils n the blood (%)	Screening, Day 0, 3, 7, and 10
Basophils	Clinical lab evaluation of level of Basophils in the blood (%)	Screening, Day 0, 3, 7 and 10
Absolute Neutrophils	Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Absolute Lymphocytes	Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Absolute Monocytes	Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Absolute Eosinophils	Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Absolute Basophils	Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Immature Granulocytes	Clinical lab evaluation of level of Immature Granulocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Absolute Immature Granulocytes	Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
International Normalized Ratio (INR)	Clinical lab evaluation of International Normalized Ratio (INR)	Screening, Day 0, 3, 7, and 10
Prothrombin Time (PT)	Clinical lab evaluation of Prothrombin Time (seconds)	Screening, Day 0, 3, 7, and 10
Partial Thromboplastin Time (PTT)	Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)	Screening, Day 0, 3, 7, and 10

Collaborators and Investigators

• Sponsor: Hope Biosciences Research Foundation
• Collaborators: United Memorial Medical Center; River Oaks Hospital and Clinics
• Investigators: Principal Investigator: Rajiv Thakur, MD, River Oaks Hospital and Clinics; Principal Investigator: Joseph Gathe, MD, United Memorial Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Stem cells; Coronavirus; COVID; Mesenchymal stem cells; Adipose-derived mesenchymal stem cells; Coronavirus disease; MSCs
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections
• Other Study ID Numbers: HBCOV03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No