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

Last updated: September 24, 2025
Sponsor: Hope Biosciences Research Foundation
Overall Status: Terminated

Phase

2

Condition

Covid-19

Treatment

Placebo

HB-adMSC

Clinical Study ID

NCT04362189
HBCOV03
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andfor 6 months after the last dose of study treatment. Highly effective methods ofbirth control include true sexual abstinence (defined as refraining fromheterosexual intercourse during the entire period of risk, in line with thepreferred and usual lifestyle of the patient), surgery (bilateral tubal ligation orocclusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonalcontraceptive associated with inhibition of ovulation (oral, patch, injectable,implantable, or intravaginal), intrauterine device (IUD), or intrauterinehormone-releasing system (IUS).

Exclusion

Exclusion Criteria:

  1. Pregnancy, lactation and those who are not pregnant but do not take effectivecontraceptive measures, in women of childbearing age. Absence of pregnancy will beconfirmed through urine pregnancy test.

  2. Patients who have participated or are participating in a clinical trial of anexperimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30days.

  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.

  1. History or evidence of alcohol abuse.

  2. History or evidence of consumption of illicit drugs.

  3. Patients requiring mechanical ventilation.

  4. Patients who are determined by the Principal Investigator to be unsuitable for studyenrollment for other reasons.

  5. Any medical disease or condition that, in the opinion of the site PrincipalInvestigator or sub-investigator, precludes study participation. Including acute,subacute, intermittent or chronic medical disease or condition that would place thesubject at an unacceptable risk of injury, render the subject unable to meet therequirements of the protocol, or may interfere with the evaluation of responses orthe subject's successful completion of this trial.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 30, 2020
Estimated Completion Date:
September 30, 2021

Study 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.

Connect with a study center

  • River Oaks Hospital and Clinics

    Houston, Texas 77027
    United States

    Site Not Available

  • United Memorial Medical Center

    Houston, Texas 77091
    United States

    Site Not Available

  • River Oaks Hospital and Clinics

    Houston 4699066, Texas 4736286 77027
    United States

    Site Not Available

  • United Memorial Medical Center

    Houston 4699066, Texas 4736286 77091
    United States

    Site Not Available

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