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.
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess
Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients
will be enrolled. Eligible participants are at high or very high exposure risk of contracting
COVID-19. The primary endpoint of this study is to provide immune support against COVID-19,
measured by the percentage of subjects that develop symptoms of COVID-19. 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.
Biological: HB-adMSCs
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
Other: Placebos
Saline
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States
Thanh Cheng, MD, Principal Investigator
Hope Biosciences Stem Cell Research Foundation