A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19

NCT04349631 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HBCOVID01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Hospitalization for COVID-19

  Number of subjects that require hospitalization for COVID-19

  Week 0 through Week 26 (End of Study)

• Incidence of Symptoms for COVID-19

  Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough

  Week 0 through Week 26 (End of Study)

Secondary Outcomes (44)

• Absence of Upper/Lower Respiratory Infection

  Week 0 through Week 26 (End of Study)

• Change From Baseline in Glucose

  Weeks 0, 6, 14, 26

• Change From Baseline in Calcium

  Weeks 0, 6, 14, 26

• Change From Baseline in Albumin

  Weeks 0, 6, 14, 26

• Change From Baseline in Total Protein

  Weeks 0, 6, 14, 26

Study Arms (1)

HB-adMSCs

EXPERIMENTAL

Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26.

Biological: HB-adMSCs

Interventions

HB-adMSCs BIOLOGICAL

Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26.

HB-adMSCs

Eligibility Criteria

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

You may qualify if:

• Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.
• Men, and women 65 years of age or older (according to CDC provisions) OR
• Participant works in healthcare facility or other well characterized high-risk environment OR
• Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease.
• Subject must have previously banked their cells at Hope Biosciences
• 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:

• Subjects must not have any of the following criteria to be eligible.
• 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.
• Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days

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 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: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 16, 2020
• Study Start: April 20, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: September 26, 2025
• Results First Posted: October 31, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)