Status:
TERMINATED
Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
Lead Sponsor:
Hope Biosciences Research Foundation
Collaborating Sponsors:
River Oaks Hospital and Clinics
United Memorial Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
Phase:
PHASE2
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04362189
Start Date
June 30 2020
End Date
September 30 2021
Last Update
September 26 2025
Active Locations (2)
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1
River Oaks Hospital and Clinics
Houston, Texas, United States, 77027
2
United Memorial Medical Center
Houston, Texas, United States, 77091