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.
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.
Biological: HB-adMSC
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
Other: Placebo
Saline
Inclusion Criteria:
- Men, and women, over 18 years of age inclusively
- Patient is hospitalized due to suspected COVID-19 infection
- Agrees to the collection of venous blood per protocol
Exclusion Criteria:
- Pregnancy, lactation and 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.
- Acute intercurrent infections such as Hepatitis C Virus (HCV), Hepatitis B Virus
(HBV), Human Immunodeficiency Virus (HIV) or Syphilis.
- 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.
- Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time
prior to or during the study.
River Oaks Hospital and Clinics
Houston, Texas, United States
United Memorial Medical Center
Houston, Texas, United States
Rajiv Thakur, MD, Principal Investigator
Advanced Diagnostics Healthcare