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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04348435

Run by

Hope Biosciences Research Foundation

People needed

53

Starts

2020-05-14

Expected to finish

2021-05-12

Last updated by the study team

2025-09-26

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Hope Biosciences Stem Cell Research Foundation — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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