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

NCT ID: NCT04349631

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2020-11-25

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.

Detailed Description

This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 51 patients were enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either 65 years of age or older, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary objective of this study is to provide immune support against COVID-19, measured by the presence or absence of adverse events and serious adverse events related to the study drug. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HB-adMSCs

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.

Group Type: EXPERIMENTAL

HB-adMSCs

Intervention Type: 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.

Interventions

HB-adMSCs

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.

1. Men, and women 65 years of age or older (according to CDC provisions) OR

2. Participant works in healthcare facility or other well characterized high-risk environment OR

3. Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease.

4. Subject must have previously banked their cells at Hope Biosciences

5. No signs or symptoms of infection, including but not limited to, body temperature >100 F and pulse rate > 100 BPM.

6. Subject provides written informed consent prior to initiation of any study procedures.

7. Agrees to the collection of venous blood per protocol.

8. Agrees to conformational testing for SARS-CoV-2 before end of study.

Exclusion Criteria

Subjects must not have any of the following criteria to be eligible.

1. Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures

2. Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days;

3. Inability to provide informed consent or to comply with test requirements;

4. 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.

5. Patients who have received a stem cell treatment within one year.

6. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.

7. Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hope Biosciences Research Foundation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thanh Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Hope Biosciences Stem Cell Research Foundation

Locations

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HBCOVID01

Identifier Type: -

Identifier Source: org_study_id