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

NCT04348435 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HBCOV02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Coronavirus; Prevention; Immune support; stem cells; mesenchymal stem cells; adipose-derived mesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 0 through Week 26 (End of Study)

• 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.

  Week 0 through Week 26 (End of Study)

Secondary Outcomes (7)

• Leukocyte Differential Count

  Week 0 to Week 26 (End of Study)

• C Reactive Protein

  Week 0 through Week 26 (End of Study)

• Tumor Necrosis Factor - Alpha

  Week 0 through Week 26 (End of Study)

• Interleukin 6

  Week 0 through Week 26 (End of Study)

• Interleukin 10

  Week 0 through Week 26 (End of Study)

Study Arms (4)

Allogeneic HB-adMSCs 200MM

EXPERIMENTAL

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

Allogeneic HB-adMSCs 100MM

EXPERIMENTAL

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

Allogeneic HB-adMSCs 50MM

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

HB-adMSCs BIOLOGICAL

Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Allogeneic HB-adMSCs 100MM; Allogeneic HB-adMSCs 200MM; Allogeneic HB-adMSCs 50MM

Placebos OTHER

Saline

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ridhima Vij, PhD
• Organization: Hope Biosciences Stem Cell Research Foundation

ridhima@hopebio.org

346-900-0340

Study Officials

• Thanh Cheng, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: May 14, 2020
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: September 26, 2025
• Results First Posted: November 17, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)