NCT04362189

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Jun 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 25, 2023

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

April 21, 2020

Results QC Date

June 7, 2023

Last Update Submit

September 24, 2025

Conditions

COVID-19

Keywords

CoronavirusStem cellsMesenchymal stem cellsAdipose-derived mesenchymal stem cellsMSCsCOVIDSARS-CoV-2Coronavirus disease

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (52)

  • D-dimer

    Day 0, 3, 7, and Day 10

  • Myoglobin

    Day 0, 3 7, and 10

  • Troponin

    Day 0, 3, 7, and 10

  • Creatinine Kinase MB (CK-MB)

    Day 0, 3, 7, and 10

  • Serum Ferritin

    Day 0, 3, 7, and 10

  • +47 more secondary outcomes

Study Arms (2)

HB-adMSCs

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

HB-adMSCBIOLOGICAL

Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

HB-adMSCs
PlaceboOTHER

Saline

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.
  • Inability to provide informed consent or to comply with study requirements.
  • 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.
  • History or evidence of alcohol abuse.
  • History or evidence of consumption of illicit drugs.
  • Patients requiring mechanical ventilation.
  • Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

River Oaks Hospital and Clinics

Houston, Texas, 77027, United States

Location

United Memorial Medical Center

Houston, Texas, 77091, United States

Location

Related Publications (1)

  • 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.

    PMID: 38188343DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory 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

  • Rajiv Thakur, MD

    River Oaks Hospital and Clinics

    PRINCIPAL INVESTIGATOR

  • Joseph Gathe, MD

    United Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

June 30, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

September 26, 2025

Results First Posted

July 25, 2023

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)